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RedHill and U.S. Army Announce Opaganib and RHB-107 Combinations with Remdesivir Show Distinct Synergistic Effect Against Ebola
https://finance.yahoo.com/news/redhill-u-army-announce-opaganib-134500031.html
Investigational drugs opaganib and RHB-107 (upamostat) demonstrate distinct synergistic effect when combined individually with remdesivir, significantly improving potency while maintaining cell viability, in a new U.S. Army-funded and conducted in vitro Ebola virus study
Opaganib and RHB-107 are both novel, oral, host-directed, small molecule investigational drugs that are easy to administer and distribute, with demonstrated activity against multiple viral targets, including COVID-19, and are expected to be effective against emerging viral variants
Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease, having recently delivered a statistically significant increase in survival time in a separate U.S. Army-funded in vivo Ebola virus study. RHB-107 was recently accepted for inclusion in the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment
TEL-AVIV, Israel and RALEIGH, N.C., Dec. 20, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that its two novel, oral host-directed investigational drugs, opaganib[1] and RHB-107 (upamostat)[2], demonstrated robust synergistic effect when combined individually with remdesivir (Veklury®)[3], significantly improving viral inhibition while maintaining cell viability, in a new U.S. Army-funded and conducted Ebola virus in vitro study.
"These encouraging in vitro results for opaganib and RHB-107 show a distinct synergy in terms of viral inhibition while maintaining cell viability (i.e., not increasing toxicity), when either is added to remdesivir, with opaganib showing the greatest synergistic effect in combination with remdesivir," said Jeffrey Kugelman, Ph.D., Major(P), US Army MSC, Branch Chief Synthetic Biology & Surveillance, Molecular Biology Division, U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), who led the bioinformatics analysis of the study. "The results suggest that opaganib and upamostat may have potential or use in combination with direct antiviral agents, such as remdesivir, to improve treatment outcome, increasing efficacy while maintaining safety."
"Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease, and these results add to a recent U.S. Army Ebola virus study in which opaganib delivered a statistically significant increase in mice survival time in vivo," said Reza Fathi, Ph.D., RedHill's SVP R&D. "Opaganib and RHB-107 are both novel, oral, host-directed, small molecule investigational drugs with demonstrated activity against multiple viral targets, including COVID-19, and are expected to be effective against emerging viral variants. This, together with their growing safety and tolerability databases, presents a compelling hypothesis for further study of their potential in treating Ebola virus."
Utilizing a checkerboard design to test the study compounds in combination, the study cell lines were pretreated and then infected with Ebola virus. The cells were fixed, washed and subjected to immunofluorescence staining using a virus-specific antibody. The raw data for the combination was analyzed to determine synergistic, additivity or antagonistic effects on viral inhibition while taking into account cell viability.
Twice daily administered opaganib has previously demonstrated benefit in late-stage clinical studies of patients hospitalized with moderate to severe COVID-19 and was selected by the NIH Radiation and Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome development.
RHB-107 successfully met its U.S. Phase 2 study primary endpoint of safety and tolerability and delivered promising efficacy results, including marked reduction in hospitalization due to COVID-19. RHB-107 was recently accepted for inclusion in the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment. The 300-patient PROTECT Phase 2 RHB-107 arm, fully funded by non-dilutive external funding sources including the U.S. government[4], has received FDA clearance to start, with the first patient expected to be enrolled in the coming weeks. The study is being conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda, and is estimated to be completed by end of 2024.
About Ebola virus disease:
According to the Centers for Disease Control and Prevention, Ebola disease is a rare and often deadly illness, caused by infection by one of a group of four viruses, known as ebolaviruses, that are found primarily in sub-Saharan Africa and are known as: Zaire, Sudan, Taï Forest (formerly Côte d'Ivoire) and Bundibugyo. Transmission of the disease is mostly through contact with an infected animal (bat or nonhuman primate), or a sick or dead person infected with an ebolavirus. The course of the illness typically progresses from "dry" symptoms initially (such as fever, aches and pains, and fatigue), and then progresses to "wet" symptoms (such as diarrhea, vomiting and unexplained hemorrhaging, bleeding or bruising) as the person becomes sicker. There are currently only two FDA-approved therapies to treat EVD caused by the Ebola virus, species Zaire ebolavirus, in adults and children; Inmazeb™, a combination of three monoclonal antibodies and Ebanga™, a single monoclonal antibody. Both are intravenously infused direct acting monoclonal antibody antivirals that bind to glycoproteins on the Ebola virus's surface to prevent the virus from entering a person's cells. There is an urgent need for host-directed small molecule therapies that may be effective against multiple strains of ebolavirus, less likely to be impacted by viral mutation, and that are easy to store, distribute and administer, especially in areas where healthcare services and infrastructures may be sub-optimal.
About Opaganib (ABC294640)
Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential diseases, including gastrointestinal acute radiation syndrome (GI-ARS), COVID-19, other viruses as part of pandemic preparedness, and cholangiocarcinoma (bile duct cancer).
Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).
Opaganib was selected by the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS).
Opaganib has received Orphan Drug designation from the FDA for the treatment of cholangiocarcinoma and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.
Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A. Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv.
Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, once-daily orally administered investigational antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 is well tolerated; in the initial COVID-19 study, among 41 patients only one reported a drug-related adverse reaction (a mild, self-limited, rash).
In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients[5].
RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.
About USAMRIID
Since 1969, USAMRIID has served as the U.S. Department of Defense's lead laboratory for medical biological defense research. The core mission is to protect the warfighter from biological threats, while also investigating disease outbreaks and threats to public health. Research conducted at USAMRIID leads to medical solutions—therapeutics, vaccines, diagnostics, and information—that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Development Command.
I have NOT asked to be informed privately,
rather that RDHL announces publicly the Q3
results.
I hear ya; was just suggesting the date of earnings could in itself be considered tradable info, so they will make that info available to the public by an announcement, and they cannot let those who contact them by phone or email or message, know that date before they announce it to “everyone”.
Upon my 3rd request over the last 2 weeks, this was the reply:
They were telling you they had not yet publicly announced…?
I did not request non public information.
This was my 3rd request for RDHL to
announce Q3 results.
Mind you, RDHL according to sec rules
results should be published one or two weeks
after the last month of each quarter.
Q4 is over in less than 2 weeks time, hence i
guess results for fiscal 2023 will be published
somewhere around 2025?
Ha!
They have to reply like that; otherwise they would be giving individuals non-public information. You might then be trading on non-public information, at some advantage over other investors.
1.3068+0.1668 (+14.6316%)
As of 01:04PM EST. Market open.
Getting better ....
1.2750+0.1350 (+11.8421%)
As of 12:29PM EST. Market open.
Nice uptick on relative robust volume.
Looks like the volume has all
but dried up.
They are not going to be good I am convinced and starting to wonder why I bought more as I should know better. These guys simply cannot quit spending I am convinced of it. My guess is they release after the market on a friday . It would be such a rdhl thing to do. Even though they regained compliance they have still yet to prove they can quit spending like drunken sailors and that is my fear on why earnings is delayed once again.
I start thinking they will publish Friday before
market close or close to Christmas in hopes
that the market will hardly notice!
Hopefully i am wrong, but anyway, according
to Sec rules:
Earnings are not going to be good I already know it if they were they would have already annonced them. Always expect the worst from these guys when it comes to earnings. Right now shorts are in control once again.
Already 10 days ago i asked when will RDHL announce
Q3 results, herewith the reply:
another day with no earnings. Something stinks.
another day with no earnings. Something stinks.
My concern as always is what in the heck is the delay? He more they delay the more worried I get.
Day's Range 0.9100 - 1.2867
With no news, just a tug of war
with shorts losing so far.
shorts will continue to pounce cause it is a very easy stock to short. They need massive news or a BO.
shorts will most likely drive it back under a buck again because the company is dead silent right now.
1.0778-0.2422 (-18.3485%)
As of 12:25PM EST. Market open.
Yikes, i think i am going to eat my hat!
I hope not I just hope they learned how to quit spending like drunken sailors.
Now we need to get earnings out of the way which always dicey with these guys. I bought more at 1.25 but I will probably end up regretting it.
Not really news, but now it is official!
RedHill Biopharma Regains Compliance with Nasdaq Minimum Bid Price Requirement
https://finance.yahoo.com/news/redhill-biopharma-regains-compliance-nasdaq-120000487.html
TEL AVIV, ISRAEL and RALEIGH, N.C., Dec. 12, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received confirmation from The Nasdaq Stock Market LLC ("Nasdaq") that it had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1) for continued Nasdaq listing, and is now compliant with applicable listing standards for continued Nasdaq listing. To regain compliance with Nasdaq Listing Rule 5550(a)(2), the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days, which was achieved on December 8, 2023.
As previously announced, on September 22, 2023, the Company reported that it had received notification that for the previous thirty consecutive business days, the bid price for the American Depositary Shares (the "ADSs") had closed below the minimum $1.00 per share requirement for continued listing. On December 11, 2023, the Company received notification from the Nasdaq Listings Qualifications Department that the ADSs had, for the last 10 consecutive business days, a closing bid price at $1.00 per share or greater, and accordingly had regained compliance with Nasdaq Listing Rule 5550(a)(2).
RedHill Biopharma Provides H1/23 Financial Results and Operational Highlights
August 17, 2023
Hence i suppose Q3 will be published Nov 17th.
Ooops, it is already Dec 12th.
Well, at least if it is positive improvement i would not mind.
Lets hope they are good they gotta increase that revenue.
1.5600 +0.2500 (+19.0840%)
Pre-Market: 5:13AM EST
Getting Better!
1.4200 +0.11 (+8.40%)
Pre-Market: 04:47AM EST
Looking Good.
Now we wait for positive Q3 results.
Happy weekend.
Well they have compliance now and the shorts will hopefully move on.
The biggest issue for me is they need to prove that they can quit spending like drunken sailors. I am still not sure whey they have not made additional staff cuts in the last year. The company has a good drug and some promise but my issue is managment and that so far they have shown no ability to stop spending like fools. They cannot just keep raising money every couple of months they need to generate enough revenue to stop that cycle.
According to the recent news, it appears you have made the right decision my friend.
Believe it or not i added yesterday
thus greatly reducing sp average.
Is it a wise step? Time will tell.
In some bizzare way i still believe
in the revival of the company!
I see your point.
First issue is to regain compliance,
Secundo is to have a not too bad
financial Q3 release plus the repeat
statement of being debt free.
Thirdly, to have some additional
US funding for this or other indication
and finally a sybstantial stockpiling contract.
Good Luck
I get that but at what price I wonder? I am guessing they are waiting to release earning til next week they want to regain compliance first tomorrow. Earnings will likely be mixed so they dont want to let shorts drive her below a buck before compliance.
How is is not dilution doesnt somebody have to exercise the warrants at a specific price?
Hard to says shorts working hard to try and get it under a buck. I have no ideas what the delay on earnings is but withe these guys I always expect the worst and hope for the no dilution.
The start of the long awaited reversal?
I sure hope so!
While that is good shorts doing all they can again to make sure is closes below buck tomorrow and does not regain compliance. This stock can never sustain any gains
May you be rewarded generously for your optimism!
Merry Christmas
Happy Hannukah!
Dropped line in $ running down river $$ looking to set the hook $$$ Merry Christmas $$$$$
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NCI
BARDA
U.S. Department of Defense
FDA Office of Orphan Products Development
Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021
Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib
(Posted 12/22/2020)
21 Ha'arba'a Street
Tel Aviv 6473921
Israel
972 3 541 3131
http://www.redhillbio.com
[1] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=1358&PID=0&IID=1899
[2] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=2432&PID=0&IID=17299
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02-07-2021
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