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You refer to arm C as the “masking arm” but Ocular in the presentation (slides 54 and 61) calls it the “comparator arm”. I think you are right, the trial is comparing Axpaxli every 6 months to Eyelea every 8 weeks, so I don’t see why they call C the comparator. I assume the purpose of C is to mask the Axpaxli arm; patients and investigators won’t know whether the injection every 6 months is Eyelea or Axpaxli. But I don’t think they said that explicitly unless there was something in the Q&A that I missed.
VKTX- Had a nice day today. They met with Oppenhiemer at noon today and have a presentation at ADA tomorrow.
Viking Therapeutics management to meet with Oppenheimer 09:12 VKTX Meeting to be held on June 21 at 12 pm hosted by Oppenheimer.
Read more at:
https://thefly.com/n.php?id=3936178
Comments abound on X. Here is one of the better ones:
$VKTX - when asked today about its Amylin program “it’s pretty interesting- it’s potent. Also can use same oral peptide technology as VK2735 https://t.co/AIXqwFNqPJ
— dough (@semodough) June 21, 2024
There are going to be a lot of scams, including quasi-legit ones, claiming a solution to the muscle-mass issue associated with weight-loss drugs.
From the Allurion website FAQ's:
How is the balloon removed?
In certain instances, the Allurion Balloon might necessitate endoscopic or surgical intervention for its removal, although typically, after around 16 weeks within your stomach, a time-activated release valve will open. This valve enables the balloon to empty and pass through the gastrointestinal tract naturally, eliminating the need for a removal procedure. *In rare cases, the Allurion Balloon may require endoscopic or surgical intervention for removal.
Good eye! Maybe Aphaia’s APHD-012 (oral glucose) should be in your compilation of oral weight-loss drugs.
Private company developing oral glucose for pre-diabetes:
Aphaia’s lead drug candidate is a proprietary oral formulation of coated glucose beads. It is designed to be released at discrete parts of the small intestine to reawaken nutrient-sensing cells that become less responsive in obesity and restore endocrine, neuroendocrine and neuronal signaling pathways.
By design of the beads, the glucose released from the formulation is not absorbed in the upper parts of the small intestine and is not systemically available, which is a key safety feature in general, but particularly in diabetic patients.
Aphaia selected glucose as its drug formulation for two key reasons. Firstly, its natural composition suggests a safer profile. Secondly, glucose maximizes nutrient-sensing cell responses, whereas other compounds may trigger insufficient or delayed hormone releases.
…this particular treatment is a kind of cheat in that its using gene therapy to mimic existing treatment…
What kind of trial design are you anticipating for the second phase-3?
I don't expect gene therapy for AMD to gain much traction for the reasons you mentioned and, more fundamentally, because AMD is the kind of multifactorial disease that is inherently challenging for gene therapy.
LGND- They do seem to have a touch. They originally got many of the compounds they licensed to Viking from their acquisition of Metabasis in 2009 for $1.6 million in cash. (It was such a small transaction, it didn't maker Dew's list of Biotech buyouts!) That is some good luck there!
LGND - For reference, another milestone payment that Ligand may be entitled to is:
Under a license agreement with Viking for VK2809, Ligand is entitled to receive a $10 million milestone upon initiation of a Phase 3 clinical trial, other potential milestone payments and royalties of 3.5% to 7.5% on future worldwide sales of VK2809 by Viking.
Do you know how this 10% in 24 days metric compares to pre-clinical data for CagriSema and/or other GLP, GIP drugs?
Presumably Sol-R.
Feel free to delete this post.
OCUL
Two of mine would be:
ZEAL—Petrelintide should not be confused with Survodutide, the GLP-1/GC agonist ZEAL is co-developing with Boehringer Ingelheim (#msg-172204950).
...FDA has moved too far toward ‘one leader can overrule all staff’ decision model.
What kind of trial design are you anticipating for the second phase-3?
Re: OCUL competition
I don't expect gene therapy for AMD to gain much traction for the reasons you mentioned and, more fundamentally, because AMD is the kind of multifactorial disease that is inherently challenging for gene therapy.
I commented on this nine years ago in #msg-113278211; gene therapies have doubtless improved since then, but the issue still pertains, IMO.
ZEAL.CO - perfoming well on interim data today on their amylin analog in a small phase 1b trial (N=20 for part one of the study)
"Zealand Pharma announces positive topline results from the Phase 1b 16-week multiple ascending dose clinical trial with long-acting amylin analog petrelintide"
https://finance.yahoo.com/news/zealand-pharma-announces-positive-topline-153700688.html
-Body weight reductions of up to a mean of 8.6% with high dose petrelintide after 16 weekly doses (1.7% with placebo)
-Petrelintide was judged to be safe and well tolerated at all dose levels
-Results provide robust support of the potential of petrelintide as an effective alternative to GLP-1RA-based therapies for weight management
-Zealand Pharma anticipates initiation of a Phase 2b clinical trial in H2 2024
Petrelintide was assessed to be well tolerated in the trial, with no serious or severe adverse events (AEs). All gastrointestinal (GI) AEs were mild except for two moderate events (nausea and vomiting) reported by one participant who discontinued treatment after the third dose. Notably, no other participants discontinued treatment due to AEs. No other participants reported vomiting and there were only two reports of diarrhea, both of which were mild. Nausea was reported by 16.7-33.3% for active groups and 16.7% for placebo. A low number of participants reported injection site reactions, all of which were mild. No anti-drug antibodies were observed.
These topline results are from an interim data cut. The final results will be based on all collected data including complete post-treatment follow-up from the third cohort. Zealand expects to present more details on the 16-week results from Part 2 of the MAD trial at a scientific conference later this year. The company also plans to rapidly progress the clinical development of petrelintide and initiate a Phase 2b clinical trial later in 2024.
OCUL
What are these three top concerns?
SRPT decisions and alzheimers decisions strongly suggest that FDA has moved too far toward ‘one leader can overrule all staff’ decision model. Even Musk, in SpaceX decision to move to a steel Starship, had to work very hard to convince his staff. He did not just overrule them, although he absolutely could have. (For those not aware… the fact that it’s steel has now turned out to be immensely important/good)
I guess the market feels GILD can expand the proportion of patients getting Prep with this because they already dominate the market despite GSK’s recent entry (which no longer looks competitive with its more frequent dosing requirement )
AVRO—>TECX at tomorrow’s open—pursuant to previously announced reverse-merger:
https://investors.tectonictx.com/news-releases/news-release-details/tectonic-therapeutic-announces-closing-merger-avrobio-well
Concurrent with the merger, Tectonic completed a $130.7 million private placement with a syndicate of new and existing investors, including a major mutual fund, TAS Partners, 5AM Ventures, EcoR1 Capital, Polaris Partners, certain funds and accounts advised by Farallon Capital Management, Vida Ventures, the PagsGroup, and other undisclosed investors. Following these transactions, Tectonic’s cash, cash equivalents and investments of approximately $181 million at close, before payment of final transaction-related expenses, is expected to fund current operational plans into mid-2027.
GILD was up sharply on the Lenacapavir data:
https://finance.yahoo.com/news/gilead-twice-yearly-lenacapavir-demonstrated-125100452.html
More on FDA’s Elevidys decision—(from BioPharma Dive):
https://www.biopharmadive.com/news/sarepta-fda-elevidys-expand-approval-duchenne-gene-therapy/716778/
Keep your eye on insurance coverage and side effects of LLY and NVO meds for weight loss, as well as GILD’s presentation at ADA conference beginning tomorrow, 6/21/2024. I have stayed out of LLY and NVO while enjoying our substantial gain in 7,550 shares of NVDA (mentioned in your WSJ story link; I purchased NVDA in 2009 at split adjusted basis of $0.434 per share). We also have 3200 shares of GILD that traded + >$5 per share today, exact reasons unknown.
FDA PR on expanded label for SRPT's Elevidys:
https://www.fda.gov/news-events/press-announcements/fda-expands-approval-gene-therapy-patients-duchenne-muscular-dystrophy
Today, the U.S. Food and Drug Administration expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD) for ambulatory and non-ambulatory individuals 4 years of age and older with DMD with a confirmed mutation in the DMD gene.
Elevidys was previously approved under accelerated approval for ambulatory individuals 4 through 5 years of age with DMD with a confirmed mutation in the DMD gene. With today’s action, Elevidys received traditional approval in ambulatory individuals 4 years of age and older with DMD with a confirmed mutation in the DMD gene, and accelerated approval in non-ambulatory individuals 4 years of age and older with DMD with a confirmed mutation in the DMD gene.
SRPT share price is ~ $174, up substantially AH on news of FDA approval of expanded indication for treatment of DMD
This_comment_to today’s WSJ piece_on obesity drugs caught_my_eye:
https://www.wsj.com/health/pharma/why-wall-street-is-chasing-ozempic-wannabes-318a20aa?siteid=yhoof2#comments_sector
I've bet my entire retirement on Eli Lilly and Novo Nordisk. I've already doubled my money.
Please, whatever you do, DO NOT attempt diet or exercise. These devastatingly effective cures to most ailments affecting Americans are the biggest impediment to my comfortable retirement.
ALUR +145% on muscle-mass PR:
https://finance.yahoo.com/news/allurion-announces-publication-data-demonstrating-120000975.html
Allurion Technologies, Inc., a company dedicated to ending obesity, today announced the publication of a study demonstrating an average lean mass gain of 5.6% in patients with an average weight loss of 14% at four months on the Allurion Program.
…In the study, 571 patients across three obesity centers treated with the Allurion Program reduced their weight on average by 13.9kg from 97.9kg to 84.0kg in just four months. Over that same period, lean mass—which includes muscle mass—increased by 2.8kg on average from 49.8kg to 52.6kg.
…All patients experienced significant reductions in body fat percentage, decreasing from 32.7% to 27.9% in just 4 months.
SAB Biotherapeutics “rebrands” as SAB BIO (LOL):
https://www.globenewswire.com/news-release/2024/06/20/2901581/0/en/SAb-Biotherapeutics-Rebrands-as-SAB-BIO.html
This is not some kind of solstice joke. The ticker symbol remains SABS.
Private company developing oral glucose for pre-diabetes:
https://www.globenewswire.com/news-release/2024/06/20/2901676/0/en/Aphaia-Pharma-Announces-Positive-Results-from-Phase-2-Trial-Evaluating-its-Lead-Drug-Formulation-for-Prediabetes-Treatment.html
Your father also got the benefit indirectly because you benefitted from his contributions.
No, it’s that it’s close to socialized medicine, so I find it ironic that people who are vehemently against socialized medicine can be adamantly opposed to getting rid of Medicare, Medicaid, or social security.
No, it’s that it’s close to socialized medicine, so I find it ironic that people who are vehemently against socialized medicine can be adamantly opposed to getting rid of Medicare, Medicaid, or social security.
Everybody pays into the system, and everybody who lives long enough gets to benefit from it regardless of whether they contributed enough to pay for their specific medical needs.
For example, someone who drops dead from a heart attack won’t get their money’s worth out of the system, but someone who undergoes expensive chemotherapy and survives benefits from the money the other person put into the system.
Win win on average.
FWIW, my father died when I was five, and I collected veterans checks until I was 18 and social security checks until I graduated from college. Took me a long time to earn enough to pay back into the system all the money I received from social security, but without it, I might not have had a successful career in the sciences and help cure cancer, even if my contribution was a minor stepping stone in a long pathway.
I agree healthcare costs are ballooning, but drugs only account for 9% or so of this spending. It's just the easiest target for politicians on both sides of the aisle.
There have been several posts on this board on the subject but this article now 9 years old is one I have posted before
https://www.newyorker.com/news/news-desk/health-cares-cost-conundrum-squared
This was recently in the NY times
https://www.nytimes.com/2024/06/17/opinion/medical-bill-trap.html
I know of so many docs that order unnecessary tests, do unnecessary procedures and surgeries - that is where the bulk of the savings could come from if we really want to tackle healthcare spending IMO
sure let's work on drug prices too, within reason without stifling innovation, but just pointing out where the real meat of the problem lies.
Yes, I have heard of Medicare. Do you think it should be abolished? Don’t you think it has been a success?
You’ve heard of Medicare, right?
Medical expenses are one of the main reasons people go into poverty or bankruptcy as they get older, leading to a reliance on Medicaid and social security disability payouts, which aren’t cheap.
Paying for reasonable preventative medical expenses is a good idea in my opinion, especially if you want to keep as many people as possible as able bodied citizens contributing to the workforce for as long as possible.
With the baby boomer population aging, of course medical expenses will go up with time, and the number of fully employed tax payers will go down, but lets make it as easy as possible for people to stay healthy and keep working.
I wonder how continued U.S. progression into socialized medicine could impact the estimate. Anyone got a balloon?
LLY Files More Lawsuits at Counterfeit Mounjaro, Zepbound sellers
https://www.msn.com/en-us/money/companies/eli-lilly-files-more-lawsuits-at-sellers-of-counterfeit-mounjaro-zepbound/ar-BB1oAzzM
Eli Lilly is stepping up its campaign against fake and counterfeit weight-loss drugs with more lawsuits against sellers of unapproved products that market themselves as Mounjaro and Zepbound.
The pharmaceutical company said Thursday that it has filed legal actions against med-spas, wellness centers and other entities that sell products purportedly containing tirzepatide, the antidiabetic medication Eli Lilly sells under the brand names Mounjaro and Zepbound.
atai Life Sciences Announces Update on Beckley Psytech’s Phase 1/2a Trial of ELE-101 (IV Psilocin) for Major Depressive Disorder, with Initial Results from Phase 1 and First Patients Dosed in Phase 2a
Thu, Jun 20, 2024, 7:00 AM EDT6 min read
https://finance.yahoo.com/news/atai-life-sciences-announces-beckley-110000192.html
atai Life Sciencesatai Life Sciences
ELE-101 is a patent-protected, synthetic formulation of psilocin, designed to offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter treatment paradigm of approximately two hours.
The Phase 2a part of the study will evaluate the safety, tolerability, subjective effects, and efficacy of a single intravenous (IV) dose of ELE-101 in 6-12 participants with Major Depressive Disorder (MDD). Results are expected in H2 2024.
The dose for Phase 2a was selected using preliminary pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 1 randomized, double-blind, placebo-controlled, single ascending dose part of the study of ELE-101 in healthy participants, which showed that it was well-tolerated with no serious adverse events. ELE-101 showed a dose-proportional PK profile and a reliable induction of short-duration psychedelic experiences.
NEW YORK and BERLIN, June 20, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced an update on Beckley Psytech’s Phase 1/2a trial of ELE-101 (NCT05434156) for people living with MDD, with initial results from Phase 1 and the dosing of the first patients in the Phase 2a part of the study.
ELE-101, a patent-protected IV formulation of psilocin, has been designed to provide consistent and controllable drug delivery in patients with neuropsychiatric conditions. As the active metabolite of psilocybin, psilocin has the potential to offer a rapid onset, significantly shorter treatment duration, and reduced inter-subject variability compared to oral formulations of psilocybin. This could enhance convenience and therapeutic outcomes for patients with depression while reducing the resource burden on healthcare systems.
The open-label Phase 2a part of the study will evaluate the safety, tolerability, subjective effects, and efficacy of a single IV dose of ELE-101 in 6-12 patients diagnosed with MDD. Patients will be assessed at various time points in the study for up to three months after dosing, with results expected in H2 2024.
The dose was selected using preliminary PK/PD data from the Phase 1 part of the study, a randomized, double-blind, placebo-controlled, single ascending dose study of ELE-101 in healthy participants. Initial data from Phase 1 supports the differentiated profile of ELE-101, showing that ELE-101:
Was well-tolerated with no serious or severe adverse events (AE) reported, and an AE profile which is consistent with other compounds in this class.
Demonstrated a dose-proportional PK profile, leading to reduced inter-subject variability compared to oral psilocybin.
Induced high-intensity, short-duration psychedelic experiences, suggesting a potential treatment time of approximately two hours in the clinic. If validated in further studies, these findings could support the development of a scalable treatment model similar to the established paradigm of Spravato®, an esketamine nasal spray for treatment-resistant depression.
Full data from the Phase 1 study is expected to be published at a later date.
Commenting on the news, Dr Srinivas Rao, Co-CEO of atai said: “The data so far on ELE-101 indicates its potential as a promising candidate for treating depression. The consistent dose delivery and dose-proportional pharmacokinetic profile are particularly encouraging, as this could reduce variability among patients. At atai we are building a pipeline of short-duration psychedelics that target in-clinic treatments of approximately two hours. In addition to ELE-101, we believe Beckley Psytech’s lead candidate, BPL-003 (an intranasal 5-MeO-DMT), and our VLS-01 (an oral transmucosal formulation of DMT) could also fit this model.”
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and was founded as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients. atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.
About Beckley Psytech
Beckley Psytech is a private clinical-stage biopharmaceutical company focused on improving the lives of people with neuropsychiatric disorders through the development of rapid-acting, short-duration psychedelic medicines. In January 2024, atai made a strategic investment in Beckley Psytech, resulting in a 35.5% ownership stake and 1:1 warrant coverage at a 30% premium on the primary issuances. atai holds a time-limited right of first refusal on a future sale of the company and an indefinite right of first negotiation for BPL-003 and ELE-101. atai and Beckley Psytech also agreed to collaborate on digital therapeutics, commercial and market access activities in preparation for future potential commercialization.
MindMed Announces Constructive End-of-Phase 2 Meeting with U.S. FDA for MM120 in Generalized Anxiety Disorder (GAD)
-Aligned on requirements for Phase 3 clinical development of MM120 for the treatment of GAD-
-Initiation of Phase 3 program remains on schedule to begin in second half of 2024-
https://www.businesswire.com/news/home/20240620626324/en/
June 20, 2024 07:00 AM Eastern Daylight Time
NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced the completion of the End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of MM120 (lysergic acid diethylamide [LSD] D-tartrate) into pivotal trials for the treatment of adults with GAD.
“On behalf of the 20 million people in the U.S. – and millions more worldwide – who are living with GAD, we are incredibly excited for the therapeutic potential that MM120 shows based on the data from the previously completed Phase 2b MMED008 trial”
Post this
“Following a constructive End-of-Phase 2 meeting with the FDA, we are pleased to have reached alignment on our Phase 3 development strategy for MM120 in GAD,” said Rob Barrow, Chief Executive Officer of MindMed. “This marks a significant milestone for MindMed and for the millions of individuals affected by GAD. We are on schedule to initiate our Phase 3 clinical program for MM120 oral dissolving tablet (ODT) in GAD in the second half of this year and look forward to sharing additional details on the design of our pivotal program in the coming months.”
The EOP2 meeting was supported by results from MindMed’s completed Phase 2b clinical trial, MMED008. The multi-center, randomized, double-blind, parallel-group, dose-finding study was designed to assess the effect of four doses of MM120 for the treatment of anxiety symptoms in participants diagnosed with GAD. In the trial, MM120 met its primary and key secondary endpoints and demonstrated a rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) at Week 4 and Week 12, with a 65% clinical response rate and 48% clinical remission rate sustained to Week 12 in the MM120 100 µg cohort. MM120 was generally well-tolerated in this trial, with most adverse events rated as mild to moderate, transient, and occurring on the dosing day and being consistent with the expected acute effects of the trial drug.
“On behalf of the 20 million people in the U.S. – and millions more worldwide – who are living with GAD, we are incredibly excited for the therapeutic potential that MM120 shows based on the data from the previously completed Phase 2b MMED008 trial,” said Daniel R. Karlin, MD, MA, Chief Medical Officer of MindMed. “Few treatment options have shown robust activity in GAD, with the last new FDA approval occurring in 2007. We are committed to bringing MM120 to people living with GAD and are excited to move into the next phase of our development program.”
About MM120
LSD (lysergide) is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM120, the tartrate salt form of lysergide, for GAD and is exploring its potential applications in other serious brain health disorders.
About Generalized Anxiety Disorder (GAD)
GAD is a common condition associated with significant impairment that adversely affects millions of people. GAD results in fear, persistent anxiety, and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things. Approximately 10% of U.S. adults, representing around 20 million people, currently suffer from GAD. This underdiagnosed and underserved indication is associated with significant impairment, less accomplishment at work and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2007.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. MindMed trades on NASDAQ under the symbol MNMD.
ABBV says Skyrizi and Rinvoq will have combined worldwide sales of $27B by 2027.
I wonder how continued U.S. progression into socialized medicine could impact the estimate. Anyone got a balloon?
Do you know how this 10% in 24 days metric compares to pre-clinical data for CagriSema and/or other GLP, GIP drugs?
Both targets mutate a lot AFAIK so I agree
This is a 10k patient phase 2. Wow. They will need to test the drug against different VOCs to assess if they really do have greater breadth of coverage
They rarely receive a large sum. Their royalties normally are in low single digits.
Sometimes they luck out. In 2019 they sold off their Novartis Promacta royalties for $850 million.
When Viking couldn't afford their products years ago Viking elected to give Ligand stock while Ligand also funded them. They've sold those off over the years probably gaining $500 to $700 million. They have just sold a > million shares and still hold 3.5%of the viking
Ligand could be one of the best management teams in the biospace.
This sentence from GOVX's PR sounds like a non sequitur:
GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T-cell responses to those parts of the virus less likely to mutate over time.
FDA approves ABBV’s Skyrizi for first-line ulcerative colitis:
https://www.prnewswire.com/news-releases/us-fda-approves-skyrizi-risankizumab-rzaa-for-ulcerative-colitis-expanding-abbvies-portfolio-across-inflammatory-bowel-disease-302176163.html
• Approval supported by two Phase 3 clinical trials that evaluated SKYRIZI for the treatment of moderate to severe ulcerative colitis: a 12-week induction study, INSPIRE,1 and a 52-week maintenance study, COMMAND
• Data showed that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, a key secondary endpoint
• SKYRIZI is the first IL-23 antagonist approved for both ulcerative colitis and Crohn's disease
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