Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
ADIL: THANKS for that link!!
Adial Pharmaceuticals Regains Compliance with Nasdaq Listing Requirement
https://www.globenewswire.com/news-release/2023/11/29/2788086/26135/en/Adial-Pharmaceuticals-Regains-Compliance-with-Nasdaq-Listing-Requirement.html
Adial Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Update
https://www.globenewswire.com/news-release/2023/11/14/2780605/26135/en/Adial-Pharmaceuticals-Reports-Third-Quarter-2023-Financial-Results-and-Provides-Business-Update.html
creeping back up, might finish the week strong here
Be careful! ADIL, Diluting 10 Million new shares, with the fluff 'news' here:
https://www.otcmarkets.com/filing/html?id=16746960&guid=4YD-kpJOCv8WJth
Up to 10,199,620 Shares of
Common Stock
This prospectus relates to the offering and resale by Alumni Capital LP (“Alumni Capital” or the “Selling Stockholder”) of up to 10,199,620 shares (the “Shares”) of our common stock, par value $0.001 per share, which includes 199,620 shares of our common stock issued to the Selling Stockholder as commitment shares (the “Commitment Shares”).
ADIL: Although VERY unlikely, this nonetheless could hit $1.00+ by day's end; but obviously I would NOT count on it. (The IMMENSITY of the NEGATIVE social & industrial impact of the subject DISEASE; & the PERSEVERANCE of this Firm towards rectifying them; have captured the ATTENTION of 'Big Phrama' companies & investors across the Globe.)
ADIL: Could start to make a RUN-UP from here; but lots of suckers' bait stuff so far.
Sanofi stops Antabuse.
Again one drug gone that emphases' even more the 'unmet need' for something that works.
ADIL should speed up things.
AIMO
Very nice day once again Protector. Bucked the downward thrust. up 17%. Gotta stay strong!
Hey Protector. You're very welcome. Love what you say it's very creative to say the least! :)
subslover, thanks for sharing.
This kind of confirms what I suspected already a few months ago when I openend a position in ADIAL. The clinical results where clear but the investors often only look at the overall result.
And that overall result is what all the pseudo news channels write about.
But I keep saying that the heavy drinkers group is MUCH larger then the very heavy drinkers. Splitting this up, given we are dealing with an unmet need, is the way to go.
AIMO
congrats to whoever was in before the news POP
Adial Pharmaceuticals Provides Update on Regulatory Strategy for AD04 for Treatment of Alcohol Use Disorder
March 06 2023 - 04:19PM
GlobeNewswire Inc.
Alert
Print
Share On Facebook
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”) a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided an update on its regulatory strategy for AD04, the Company’s lead compound for the treatment of Alcohol Use Disorder (AUD).
Key highlights:
Additional analysis of ONWARD™ data identified specific genotypes that outperformed others
Type C meeting with FDA confirmed for Q2 2023 to discuss clinical program in U.S.
Meetings scheduled or planned with five European country-level regulatory authorities
Advancing discussions with potential U.S. and European partners
Market research commissioned by Adial subsequent to completion of the ONWARD trial suggests unit pricing for AD04 could be more than double the previous assumptions
Adial’s lead compound, AD04, is a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and was recently investigated in a Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which were identified using the Company’s companion diagnostic genetic test. ONWARD results showed that AD04 achieved a statistically significant reduction of heavy drinking days in a subgroup of patients - the “heavy drinkers.” The “heavy drinker” population, defined as patients who drank fewer than 10 drinks per drinking day prior to enrollment, accounted for approximately two-thirds of the trial population.
Based on the ONWARD trial results, and after discussions with its regulatory advisors and key opinion leaders (KOLs), Adial believes there is a clear, cost-effective path toward FDA approval that it plans to aggressively pursue. This decision was based on a detailed analysis of both the prior Phase 2 clinical trial and the recently completed ONWARD Phase 3 clinical trial. These results were reviewed with regulatory and statistical experts to confirm their validity. Additionally, after these results were analyzed and confirmed, Adial engaged commercial experts to confirm the value of this data as tested through market research with physicians and payers.
This detailed analysis of the Phase 2 and Phase 3 data identified two specific genotypes that Adial believes can meet the FDA’s prespecified, confirmed and recommended primary endpoint, which is to measure the proportion of patients who attain and sustain zero heavy drinking days in a pre-specified efficacy observation period, which was months five and six of the six-month study period in ONWARD. The prevalence of patients with these genotypes, which performed best during the trials, is estimated to exist in about 20% of the AUD population.
Based on the information collected and analyses to date, Adial has submitted a Type C meeting request to the FDA and was granted a meeting, which will be held in Q2 of 2023. The Type C meeting is expected to provide Adial with confirmation of a clear clinical development plan. As previously anticipated, it is possible an additional Phase 3 trial will be required. Adial currently intends to engage a U.S. partner to assist with funding the required clinical trial and, assuming a successful outcome with FDA, to advance commercialization efforts. Adial is exploring partnerships with companies that have an established commercial presence and existing relationships with psychiatrists and addiction specialists. With an experienced partner, Adial believes it can rapidly penetrate the U.S. market given the expectation of AD04 being widely accessible, reasonably priced, and reimbursable.
Furthermore, Adial is progressing discussions with five European country-level regulatory authorities: France, Sweden, Finland, the United Kingdom, and Germany. Meeting dates with Sweden and Germany are scheduled for March and April of 2023, respectively, and the schedule for the remaining countries are pending confirmation. The expected outcome from these meetings would be to gain a clear understanding from these regulatory authorities regarding the most expeditious path to approval in Europe. This would include whether any additional trials would be required. Additionally, Adial is in ongoing discussions with potential commercial partners in Europe, which it believes have the capability to accelerate AD04’s path to market and maximize impact in Europe.
Cary Claiborne, President and Chief Executive Officer of Adial, commented, “We have finalized and are actively pursuing a regulatory strategy that we believe will bring AD04 to the commercial stage within important global markets in the shortest timeframe possible—initially focusing on the U.S. and Europe. Importantly, as a result of further analysis, we identified specific genotypes that have responded very well to AD04, and by combining these genotypes with the heavy drinker sub-group, we have a high level of confidence that we will be able to meet the FDA’s prespecified responder analysis primary endpoint to obtain FDA approval. We have always anticipated the need for an additional Phase 3 trial to meet the required FDA primary endpoint. Engaging a partner with the appropriate resources and market reach is expected to allow us to advance the clinical program and bring AD04 to the large U.S. market in the most cost-effective and time-sensitive way possible. It is also important to note that market research commissioned by Adial subsequent to the completion of the ONWARD trial suggests that unit pricing for AD04 could be more than double our previous assumptions. As a result, even after factoring in the current target genotypes, the market opportunity could be significantly larger than our earlier expectations.”
Mr. Claiborne continued, “At the same time, we are aggressively pursuing regulatory approval in Europe and are in active discussions with potential strategic partners. Overall, we believe we have a well-vetted strategy with a high likelihood of success, designed to maximize value for shareholders, while providing new hope for the millions of people suffering from AUD.”
AUD is a potentially multi-billion-dollar market with limited competition and a significant unmet need. Failure to help people with AUD is a major health, social and financial problem. AUD is also the leading cause of death for people ages 15-49, it contributes to over 200 different diseases, and more than 10% of children live with a person with an alcohol problem. Additionally, AUD costs the U.S. economy approximately $250 billion every year.
Conference Call
The Company will host a conference call at 8:15 a.m. Eastern Time today, March 7, 2023, to provide an update on its regulatory and partnering strategy for the United States and Europe. The company will also present and discuss the findings from its subgroup analysis of ONWARD data.
A live audio webcast of the conference call and accompanying slide presentation may be accessed at https://www.webcaster4.com/Webcast/Page/2463/47766, or on the investor relations section of the company’s website at https://www.adial.com/news-events/. The conference call will also be available via telephone by dialing toll-free +1 888-506-0062 for U.S. callers or +1 973-528-0011 for international callers and entering access code 737117. Participants that dial into the call may obtain the accompanying slides on the investor relations section of the Company’s website at https://www.adial.com/news-events/.
A webcast replay will be available on the investor relations section of the company’s website at https://www.adial.com/news-events/ through March 7, 2024. A telephone replay of the call will be available approximately one hour following the call, through March 21, 2023, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and entering access code 47766.
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes (estimated to be approximately one-third of the AUD population) identified using the Company’s companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. The Company is also developing adenosine analogs for the treatment of pain and other disorders. Additional information is available at www.adial.com.
Forward Looking Statements
This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding the Company’s regulatory strategy for AD04, the Company’s plans to meet with multiple European regulatory authorities, there being a clear, cost-effective path toward FDA approval that the Company plans to aggressively pursue, there being two specific genotypes that can meet the FDA’s prespecified, confirmed and recommended primary endpoint, the prevalence of patients with the two genotypes existing in about 20% of the AUD population, the Type C meeting with the FDA providing Adial with confirmation of a clear clinical development plan, engaging a U.S. partner to assist with funding in the event an additional Phase 3 trial will be required, advancing commercialization efforts, exploring partnerships with companies that have an established commercial presence and existing relationships with psychiatrists and addiction specialists, the Company being able to rapidly penetrate the U.S. market with an experienced partner, AD04 being widely accessible, reasonably priced, and reimbursable, gaining a clear understanding from the regulatory authorities in France, Sweden, Finland, the United Kingdom, and Germany regarding the most expeditious path to approval in Europe, continuing discussions with potential commercial partners in Europe, accelerating AD04’s path to market and maximizing its impact, engaging a partner with the appropriate resources and market reach allowing the Company to advance the clinical program and bring AD04 to the large U.S. market in the most cost-effective and time-sensitive way possible, the unit pricing for AD04 being more than double the Company’s previous assumptions, the market opportunity for AD04 being significantly larger than the Company’s earlier expectations, having a well-vetted strategy with a high likelihood of success, maximizing value for shareholders while providing new hope for the millions of people suffering from AUD and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to implement our regulatory strategy for AD04 with the regulatory authorities in the U.S. and Europe and accelerate its path to market, our ability to engage a U.S. partner to help us to fund clinical development and advance AD04 commercialization efforts, our ability to partner with companies that have an established commercial presence and existing relationships with psychiatrists and addiction specialists, our ability to penetrate the U.S. market with an experienced partner, our ability to engage potential commercial partners in Europe, our ability to complete clinical trials on time and achieve desired results and benefits as expected, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate, our ability to establish and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2021, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
Contact:
Crescendo Communications, LLC
David Waldman / Natalya Rudman
Tel: 212-671-1021
Email: adil@crescendo-ir.com
Primary Logo
Adial Pharmaceuticals (NASDAQ:ADIL)
Historical Stock Chart
From Feb 2023 to Mar 2023 Click Here for more Adial Pharmaceuticals Charts. Adial Pharmaceuticals (NASDAQ:ADIL)
Historical Stock Chart
From Mar 2022 to Mar 2023 Click Here for more Adial Pharmaceuticals Charts.
Opened a position in ADIL.
- Heavy drinkers are the biggest group and in practice are those that get help and treatment more than the very heavy drinkers. Very heavy drinkers have a stronger physiologic addiction and are more in denial.
- Stat. Sig. in heavy drinkers (0.003) is super for a near 90% response. Splitting groups (heavy and very heavy drinkers) is allowed. It is overly clear that the very heavy drinkers placebo group had a strong placebo effect and started to drink less. So there is no reasons that groups could not be split.
- AUD has currently no strongly approved treatment (unmet need)
- The market is huge, which makes me think that a BP could make an offer on this (low amount of outstanding shares, low price, this is pocket money and for ADIL it would be bingo. win-win)
- ADIL PPS is mainly down because the play-press like the fool titled the trial as a failure and did not emphasize the value of the only group of interest: heavy drinkers (but what else is new). Created a perfect window of opportunity to get in low (below 2$).
- Management brings these results to US/European regulators and this looks like the best thing around for treatment of AUD. In all cases, and no matter the 0.007 stat. sig. if very heavy and heavy drinkers are joined, this still is better than whatever is out there now.
Note there is no real SOC (Standard of Care) for this, the best those AUD patients can get is some drug that has been approved for something else ( a neural condition) that probably (speculation) does them more harm then good.
I wanted to have this stock now (bought it at 1.49$ posting (HERE) that I expected it to go down even more because I placed a large AON order, and AON orders tend to have that effect).
The reason that I want it now, knowing that any regulators procedure will take at least 24 months is that I suspect that some BP will see the huge market and may be willing to place money in this because with the results at hand, doing a new heavy drinkers only clinical trial is nothing for BP. They up the participants and do the test way faster then anybody else, certainly with the current results to convince dockers in treatment centers.
So I want to be onboard now, because a thing like that happens WITHOUT any warning.
And for those of you that are in at even higher prices, 'don't panic' :)
AIMO
PS: I post mostly on the CDMO board here on IHUB because I follow things in depth and do not trade anymore (occasionally I do a trade, but mostly invest). I look at ADIL as an investment.
Good result for a PIII, a registrational trial.
No decent treatment for AUD (unmet need). If the company plays this right this stock could be an hidden potential. Might take some time so not for traders IMO, but give this 24 months.
AIMO
$ADIL another heavy volume day heading into tomorrows announcement.
I saw the pr. Thanks
Click on the news tab here on the I-Hub ADIL page.....
How do u know it’s wed
Somebody thought they were smart to dump before a bad news Friday afternoon. Not a bad strategy because if there is bad news Friday after hours would be when most companies would release it
Instead they are announcing top line on wed and have a conf call.
Could still be bad news but more likely to be good news
Jmo
Well above it's avg 10 day volume again.
it's chugging up there. Will likely explode on positive data.
I think this week, but no later than next.
When do we get data release
Looking so good here.
GLTA
Peace
mis
$ADIL 30,800 @ $1.78 in a/hs trading. New HOD.
Heavy volume day again.
I think they take it up here on the data. 6/7ish? area before some retrace.
They were trying to test for supply, and i got some!
Let's get that gap above and while we are up there let's get those warrants exercised! LFG!
I think the key to their trials is they use the diagnostic to identify those that will respond more favorablly. I'm long here large. LFG!
$ADIL heavy volume last 2 days.
Very nice article I found on stocktwits.
https://investor-strategy.com/adial-pharmaceuticals-2022/
LONG Baby. dip it down some more for me to load up.
Misleading headline from seekingalpha has caused big pop in stock price...
https://seekingalpha.com/article/4435908-revisiting-adial-pharmaceuticals-ema-approval-for-alcohol-use-disorder-pill-is-a-critical-catalyst
There has been NO ema approval yet!!
Adial Pharmaceutical (ADIL)
3.0 ? 0.04 (1.35%)
Volume: 502,361 @02/19/21 7:55:08 PM EST
Bid Ask Day's Range
3.0 3.01 2.83 - 3.05
ADIL Detailed Quote
I’m going long from here~ Nice bullish close
$8+ in the works imo....
https://swingtradebot.com/equities/ADIL
Followers
|
24
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
244
|
Created
|
12/21/18
|
Type
|
Free
|
Moderators |
"We decided to enter into this agreement with Keystone as we believe they have a strong fundamental understanding our business,
and are an ideal strategic partner to support any financial needs that may arise," said William Stilley, CEO of Adial Pharmaceuticals.
"We have no immediate plans to raise capital, with over $7 million of cash on hand as of September 30, 2020;
however, this transaction provides additional flexibility and capability to take advantage of strategic opportunities and future growth initiatives when they may arise."
"We are pleased to enter into this relationship with Adial," said Fred Zaino, Managing Partner and Chief Investment Officer of Keystone.
"After evaluating Adial, its clinical pipeline, and its management team, and after thorough due diligence, we believe Adial represents a promising investment opportunity.
Formation of this partnership memorializes our intention to build a long-term relationship with Adial, committing
capital as necessary as the Company builds its business in the growing space of addiction that is currently woefully underserved."
September 1, 2020 • 9:00am EDT
https://ir.adialpharma.com/stock-datahttps://ir.adialpharma.com/company-information
Shs Outstand | 11.29M |
Shs Float | 10.55M |
Short Float | 2.96% |
Insider Own | 6.20% |
Book/sh | 0.78 |
Debt/Eq NO DEBT | 0.00 |
52W Range | 1.00 - 3.17 |
% Held by Insiders | 49.12% |
https://www.sec.gov/Archives/edgar/data/1513525/000121390017012521/fs12017a3_adialpharma.htm
Overview
We are a clinical-stage biopharmaceutical company focused on the development of a therapeutic agent for the treatment of alcohol use
(“AUD”) using our lead investigational new drug product, AD04, a selective serotonin-3 antagonist (i.e., a “5-HT3 antagonist”).
The active ingredient in AD04 is ondansetron, which is also the active ingredient in Zofran®, an approved drug for treating nausea and emesis.
AUD is characterized by an urge to consume alcohol and an inability to control the levels of consumption. We intend to commence
a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes.
We believe our approach is unique in that it targets the serotonin system and individualizes the treatment of AUD, through the use of genetic screening.
We have created an investigational companion diagnostic biomarker test for the genetic screening of patients with certain biomarkers that, as
reported in the American Journal of Psychiatry (Johnson, et. al. 2011 & 2013), we believe will benefit from treatment with AD04. Our strategy is to integrate
the pre-treatment genetic screening into AD04’s label to create a patient-specific treatment in one integrated therapeutic offering.
Our goal is to develop a genetically targeted, effective and safe product candidate to treat AUD that does not require abstinence as part of the treatment.
We have a worldwide, exclusive license from the University of Virginia Patent Foundation (d.b.a the Licensing & Venture Group) (“UVA LVG”),
which is the licensing arm of the University of Virginia, to commercialize our investigational drug candidate, AD04, subject to Food and Drug Administration
(“FDA”) approval of the product, based upon three separate patents and patent application families, with patents issued in over 40 jurisdictions,
including three issued patents in the U.S. Our investigational agent has been used in several investigator-sponsored trials and we possess or have rights to use toxicology,
pharmacokinetic and other preclinical and clinical data that supports our Phase 3 clinical trial.
Our therapeutic agent was the product candidate used in a University of Virginia investigator sponsored Phase 2b clinical trial of 283 patients. I
in this Phase 2b clinical trial, ultra-low dose ondansetron, the active pharmaceutical agent in AD04, showed a statistically significant difference
between ondansetron and placebo for both the primary endpoint and secondary endpoint, which were reduction in severity of drinking measured in drinks per drinking day
{1.71 drinks/drinking day; p=0.0042), and reduction in frequency of drinking measured in days of abstinence/no drinking (11.56%; p=0.0352), respectively.
Additionally, and importantly, the Phase 2b results showed a significant decrease in the percentage of heavy drinking days (11.08%; p=0.0445)
with a “heavy drinking day” defined as a day with four (4) or more alcoholic drinks for women or five (5) or more alcoholic drinks for men consumed in the same day.
The active pharmaceutical agent in AD04, our lead investigational new drug product, is ondansetron (the active ingredient in Zofran®),
which was granted FDA approval in 1991 for nausea and vomiting post-operatively and after chemotherapy or radiation treatment and is now commercially
available in generic form. In studies of Zofran® conducted as part of its FDA review process, ondansetron was given acutely at dosages up to almost 100 times the dosage
expected to be formulated in AD04 with the highest doses of Zofran®given intravenously (“i.v.”), which results in almost twice the exposure level as oral dosing.
Even at high doses given i.v. the studies found that ondansetron is well-tolerated and results in few adverse side effects at the currently marketed doses,
which reach more than 70 times the AD04 dose and are given i.v. The formulation dosage of ondansetron used in our drug candidate
(and expected to be used by us in our Phase 3 clinical trials) has the potential advantage that it contains a much lower concentration of ondansetron than the
generic formulation/dosage that has been used in prior clinical trials, is dosed orally, and is available with use of a companion diagnostic biomarker.
Our development plan for AD04 is designed to demonstrate both the efficacy of AD04 in the genetically targeted population and the safety of ondansetron when administered chronically at the AD04 dosage.
However, to the best of our knowledge, no comprehensive clinical study has been performed to date that has evaluated the safety profile of ondansetron for long-term use as anticipated at any dosage.
According to the National Institute of Alcohol Abuse and Alcoholism (the “NIAAA”) and the Journal of the American Medical Association (“JAMA”), in the United States alone,
approximately 35 million people each year have AUD (such number is based upon the 2012 data provided in Grant et. al. the JAMA 2015 and has been adjusted to reflect
a compound annual growth rate of 1.13%, which is the growth rate reported by U.S. Census Bureau for the general adult population from 2012-2017), resulting in significant health,
social and financial costs with excessive alcohol use being the fourth leading cause of preventable death and is responsible for 31% of driving fatalities in the
United States (NIAAA Alcohol Facts & Statistics). AUD contributes to over 200 different diseases and 10% of children live with a person that has an alcohol problem.
The Centers for Disease Control (the “CDC”) has reported that AUD costs the U.S. economy about $250 billion annually,
with heavy drinking accounting for greater than 75% of the social and health related costs. Despite this, according to the article in the JAMA 2015 publication,
only 7.7% of patients (i.e., approximately 2.7 million people) with AUD are estimated to have been treated in any way and only 3.6% by a physician (i.e., approximately 1.3 million people).
In addition, according to the NIAAA, the problem in the United States appears to be growing with almost a 50% increase in AUD prevalence between 2002 and 2013.
Our Proposed Solution
Our goal is to develop an effective and safe product to treat AUD that does not require abstinence as part of the treatment and does not have the negative side effects of the current drugs on the market.
Our product candidate is designed for patients who desire to control their drinking but cannot or do not want to completely abstain from drinking.
By removing the difficulties associated with abstinence and the side effects associated with the other current products on the market, we believe that we may be able
to remove barriers to patient adoption that inhibit adoption of current therapies and can attract a greater portion of the many millions of patients with AUD that remain untreated.
Unlike other therapies, our investigational product, AD04, uses a novel mode of action for treating AUD that involves genetic screening with a companion diagnostic genetic test
prior to treatment and is designed to reduce cravings for alcohol to effectively curb alcohol intake, without the requirement of abstinence prior to or during treatment.
Our product candidate is intended to be easy to use since it is administered orally, currently on a twice daily basis and with a once-a-day tablet planned as part of the product’s life cycle management. T
o date, clinical testing of AD04 has shown it to have a positive safety and tolerability profile with side effects similar to placebo.
The companion diagnostic genetic test to be used to identify patients that are most likely to benefit from treatment with AD04 may potentially enhance the likelihood of a successful outcome for those undergoing treatment.
Additionally, it may provide doctors with the opportunity to have a non-threatening conversation about alcohol with their patients
and may provide the patient an acceptable path to help them determine if they might be a candidate for help with their alcohol use.
If the test results are positive, they would have a science based rationale for their treatment, which reduces some of the stigma patients might otherwise endure,
and allows them to be treated in the confidence of their doctor, potentially with a simple, oral tablet.
Large Market Opportunity for an Effective Solution
As stated above, in the United States alone, it is estimated that approximately 35 million people have AUD in 2017.
Based on data from the Phase 2b trial of AD04 and our analysis of publicly available genetic databases, we preliminarily estimate that about one in three patients with AUD in the U.S.
will have the genetic markers to indicate possible treatment with AD04.
At this time, we are not aware of any oral pharmaceutical treatment approved in the U.S. that addresses the needs of patients who desire
to control their drinking but cannot or do not want to abstain from drinking. The current abstinence-based treatments have limitations.
The limited side effects expected for our investigational new drug, based on clinical data so far, are also believed to be an important factor in the expected market acceptance of AD04.
Our approach, if approved by FDA, may allow for social drinking to continue and is aimed at reducing dangerous, heavy drinking. This would allow patients to live the life they want
without the stigma associated with complete abstention and currently endured by those seeking help for their excessive drinking.
Assuming that one-third of AUD patients are genotype positive for treatment with AD04 and a $235 price for a one month supply of the drug (assumed pricing based on
an average of prices published by Blue Cross Blue Shield in June 2017 for tier-3 oral, on-patent, chronic maintenance drugs, discounted by 16.6%, to reflect the average
difference between retail and wholesale pricing for branded drugs as reported by drugs.com), and that all such patients are treated with AD04,
the total potential market for AD04 would be approximately $36 billion in the United States alone.
Beyond the United States, alcohol consumption worldwide is a serious health issue.
The 2014 Global Status Report on Alcohol and Health published by the World Health Organization (the “WHO”) states that 5.9% of all deaths (about 3.3 million per year)
and 5.1% of disease worldwide are attributable to alcohol consumption.
Europe consumes over 25% of the total alcohol consumed worldwide despite only having 14.7% of the world’s population.
The WHO estimates that about 55 million people in Europe have AUD and, within Europe, Eastern Europe has a particularly acute problem with Russia estimated to have about 21 million people with AUD.
The WHO further estimates that 17.4% of adult Russians and 31% of adult Russian males have AUD,\
and the Organization for Economic Cooperation and Development data indicates that 30% of all deaths in Russia are alcohol related as reported by Quartz Media.
Our Strategy
We develop pharmaceutical treatments for addictions and addictive disorders. The focus of our business strategy is to advance AD04, our lead investigational drug candidate,
toward regulatory approval for alcohol addiction in the United States, the European Union, and then eventually other territories.
We subsequently plan to develop label expansions into other indications (e.g., drug addiction, obesity, smoking cessation, eating disorders and anxiety).
Our goals in executing this strategy are to keep capital requirements to a minimum, expedite product development,
gain access to clinical research and manufacturing expertise that will advance product development, approval and eventual market uptake of our product,
and rely on a well-defined and carefully executed intellectual property strategy in order to position AD04 with long-term, defensible, competitive advantages.
Execution of this strategy may include seeking grant funding and funding from partners and collaborators when available on terms we believe to be favorable to us.
Our near-term strategy includes:
• Obtaining regulatory approval for our lead product in the United States and Europe. We intend to commence Phase 3 clinical trials for the treatment of AUD.
The first Phase 3 trial is planned to be conducted in Scandinavia and Central and Eastern Europe, where the genetic prevalence of the target genotypes appear to be higher.
If our initial Phase 3 clinical trial is successful we expect to conduct a second, and possibly a third,
Phase 3 clinical trial in the same areas but with additional clinical sites in the United States and Western Europe.
• Prosecuting and expanding our intellectual property and product portfolio.
We have acquired rights to a promising drug candidate and made a significant investment in the development of our licensed patent portfolio
to protect our technologies and programs, and we intend to continue to do so.
We have obtained exclusive rights to three different patent families directed to therapeutic methods related to our AD04 platform.
These families include 3 issued U.S. patents, and at least one foreign equivalent patent covering AD04 issued in over 40 jurisdictions, including most of Europe and Eurasia.
Divisional and continuation applications to expand the coverage have also been filed in certain jurisdictions.
We intend that product portfolio expansions will be focused on promising addiction therapies and/or late-stage clinical assets.
• Evaluating the additional use of our product candidate in other indications.
In addition to alcohol addiction, we plan to conduct exploratory work to investigate using AD04 as a potential treatment for opioid addiction,
gambling addiction, smoking cessation, obesity, and other addiction related disorders in which 5-HT3 antagonism may have a treatment effect.
We believe we will be able to undertake this initial exploratory effort with minimal additional cash cost to our company through the use of
academic partnerships, grants, human laboratory studies and/or non-clinical studies.
We believe that, due to its hypothesized mechanism of action (i.e., the modulation of the serotonin system in patients that are genetically targeted based
on the apparent sensitivity to such modulation, where the modulation appears to reduce cravings),
AD04 has the potential to be used for the treatment of such other addictive disorders.
To date, we have not discussed these potential uses with the FDA or any other regulatory bodies.6
• Maximizing commercial opportunity for our technology. Our lead product candidate targets large markets with significant unmet medical need.
We intend to develop an extended release, once-a-day formulation of AD04 to enhance patient compliance and market appeal.
• Managing our business with efficiency and discipline. We believe we have efficiently utilized our capital and human resources to develop
and acquire our product candidate and programs, and create a broad intellectual property portfolio.
We operate cross-functionally and are led by an experienced management team with backgrounds in developing product candidates.
We use project management techniques to assist us in making disciplined strategic program decisions and to attempt to limit the risk profile of our product pipeline.
Companion Genetic Bio-Marker Aimed at Identifying Patients Most Likely to Respond To Treatment, Potentially Results in Increased Use of AD04
We believe our drug is unique in that it is designed to treat individuals with certain genotypes.
We are pursuing a strategy that aims to integrate pre-treatment screening with the companion diagnostic genetic test into the drug label,
essentially combining the test and treatment into one integrated therapeutic offering that has combined intellectual property protections.
This companion diagnostic testing approach may be a useful genetic screening tool to predict those most likely to respond to the drug and to have minimal side effects.
Based on the clinical experience to date and publicly available databases, we believe the genetic prevalence of genotype positive people is
about 33% of the population in the United States and that the prevalence in certain areas of Eastern Europe and in Scandinavia may be greater than 50%.
The FDA has agreed that the Phase 3 trials of AD04 can proceed only enrolling patients that are genotype positive, which greatly reduces, the cost,
time and risk relative to a trial that also enrolled patients that are genotype negative for treatment with AD04.
Our plan to conduct our first Phase 3 trial in geographic areas with expected higher prevalence of genotype positive patients should further reduce the cost,
time and risk to achieve Phase 3 results. The FDA has indicated that any approval based on a trial only in genotype positive patients would result in labeling restricted to treating genotype positive patients.
We believe that the companion diagnostic genetic test enables physicians to more easily have an initial conversation with their patients about alcohol use and,
for the patient, provides a less threatening and obtrusive first step toward treatment because the conversation will include the topic of genetic testing and not be solely about behavior.
Patients that then test positive against the AD04 genetic panel would be expected to be more likely to then receive a prescription for
AD04 (based on an external quantitative market study of 156 primary care physicians and psychiatrists that was conducted by Ipsos-Insight LLC,
who we commissioned,
and that concluded a majority of genetically targeted patients currently receiving pharmacologic treatment would be switched to a drug with the characteristics expected for AD04).
$ADIL https://www.otcmarkets.com/stock/ADIL/disclosure
https://www.otcmarkets.com/stock/ADIL/news
https://www.otcmarkets.com/stock/ADIL/security
https://www.otcmarkets.com/stock/ADIL/profile
https://www.otcmarkets.com/stock/ADIL/quote
https://www.otcmarkets.com/stock/ADIL/overview
*DISCLAIMER *The Board Monitor and The Board Assistants herewith, are not licensed brokers and assume NO responsibility for the actions, investment decisions, and or messages posted on this forum.
• We do NOT recommend that anyone buy or sell any securities posted herewith. Any trade entered into risks the possibility of losing the funds invested.
• There are no guarantees when buying or selling any security.
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |