Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Attached hereto and incorporated by reference herein is a press release issued by the Registrant entitled: “RedHill Biopharma Secures U.S. Government Funding through BARDA to Advance Opaganib for
Ebola Treatment”.
This Form 6-K is hereby incorporated by reference into the Company's Registration Statements on Form S-8 filed with the Securities and Exchange Commission on May 2, 2013 (Registration No.
333-188286), on October 29, 2015 (Registration No. 333-207654), on July 25, 2017 (Registration No. 333-219441), on May 23, 2018 (Registration No. 333-225122), on July 24, 2019 (File No. 333-232776), on March 25, 2021 (File No. 333-254692), on May
3, 2021 (File No. 333-255710), on January 11, 2022 (File No. 333-262099), on June 27, 2022 (File No. 333-265845), on June 29, 2023 (File No. 333-273001) and on June 20, 2024 (File No. 333-280327), and its Registration Statements on Form F-3 filed
with the Securities and Exchange Commission on March 30, 2021 (File No. 333-254848), on August 4, 2023 (File No. 333-273709), on October 13, 2023 (File No. 333-274957), as amended, and on August 9, 2024 (File No. 333-281417).
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
RedHill Biopharma Secures U.S. Government Funding
through BARDA to Advance Opaganib for Ebola Treatment
The U.S. government’s Biomedical Advanced Research and Development Authority (BARDA)
selected opaganib for joint development & funding as a medical countermeasure (MCM) to treat
Ebola virus disease (EBOV)
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The funding advances opaganib’s positive development progress to date on the expected FDA
Animal Rule pathway toward potential approval as an MCM for EBOV
--
Recent U.S. Army-funded studies showed that opaganib delivered a statistically significant increase
in survival in an in vivo EBOV model. The BARDA research and development contract provides
initial funding for the collaboration, in pursuit of advancing opaganib to mitigate infection and
contain EBOV outbreaks
--
This year marks the 10th anniversary of the West Africa Ebola epidemic in which 11,000 people died,
and there is still an urgent need for effective and useable therapies, with EBOV proving fatal in
around half of all cases according to the World Health Organization (WHO)1
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Opaganib, a novel potentially broad-acting drug, has shown mutation-resistant antiviral and anti-
inflammatory activity, likely to directly impact vascular health - one of the main targets for EBOV
dysfunction. It is believed to be the first host-directed molecule to show activity in EBOV in vivo and
represents an alternative host-directed therapeutic strategy for biodefense and global health
preparedness. Additional U.S. government collaborations with opaganib are ongoing
--
Significant geopolitical and logistical challenges exist in managing outbreaks of disease and there is
an urgent need for safe and effective, oral, small molecule therapeutics that can be stored and easily
distributed and administered in an outbreak
TEL-AVIV, Israel / RALEIGH, NC, October 14, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty
biopharmaceutical company, today announced that the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA), a center of the Department of Health and Human Services (HHS)’ Administration for Strategic Preparedness and
Response (ASPR), has selected opaganib2 for development to treat exposure to Ebola virus disease (EBOV).
Under this cost-sharing contract, BARDA will provide partial funding for the company to further advance opaganib to mitigate infection and contain EBOV outbreaks. To date, opaganib has made
positive development progress on the expected Animal Rule pathway towards potential approval as a treatment for EBOV. The Animal Rule allows for the use of pivotal animal model efficacy studies to support U.S. Food and Drug Administration (FDA)
approval of new drugs when human clinical trials are not ethical or feasible.
“EBOV is deadly, killing, on average, half of all those who contract it. This year marks 10 years since the West Africa Ebola epidemic in which 11,000 people died, and yet there are still no
host-directed, small molecule therapies approved to provide effective and useable treatment strategies,” said Guy Goldberg, RedHill’s Chief Business Officer. “Currently only Inmazeb™, a combination of
three monoclonal antibodies, and Ebanga™, a single monoclonal antibody, are FDA-approved to treat EBOV, as such there is an urgent medical need for additional effective and easy to distribute and administer EBOV therapies. There are also enormous
geopolitical and logistical challenges to overcome in managing outbreaks such as EBOV, and others like Mpox, and so new host-directed, small molecule therapeutic options for biodefense and global health preparedness could prove to be major
life-saving advances – this is especially true if they are capable of viral mutation-resistance, have extended shelf-lives for long-term storage, are relatively straightforward to transport to hard-to-reach territories, and are easy to administer
without the need for cold-storage or injections.”
Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases
(USAMRIID) in vivo EBOV study, making it the first host-directed molecule to show activity in EBOV. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with
remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro EBOV study.
Opaganib is currently also in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, acute respiratory distress syndrome (ARDS)
and radiological and chemical protection or mitigation.
This project is supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced
Research and Development Authority (BARDA), under contract number 75A50124C00059.
About Ebola virus disease:
According to the Centers for Disease Control and Prevention (CDC), Ebola disease is a rare and often deadly illness, caused by infection by one of a group of four viruses, known as ebolaviruses.
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. Currently only Inmazeb™ (atoltivimab, maftivimab, and
odesivimab-ebgn, Regeneron Pharmaceuticals, Inc.), a combination of three monoclonal antibodies and Ebanga™ (ansuvimab-zykl, Ridgeback Biotherapeutics, LP), a single monoclonal antibody, are FDA-approved to treat EBOV. Both are intravenously
administered 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 indications, including several cancers, diabetes and obesity-related disorders, gastrointestinal acute radiation syndrome (GI-ARS), Sulfur Mustard exposure, COVID-19, Ebola
and other viruses as part of pandemic preparedness.
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 has been selected for evaluation by multiple NIH-funded U.S. government countermeasures programs: The Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute
of Allergy and Infectious Diseases (NIAID), part of the HHS National Institutes of Health, for the nuclear medical countermeasures (MCM) product development pipeline selected opaganib for development as a potential treatment for Acute Radiation
Syndrome (ARS). Opaganib will also be evaluated as a potential countermeasure for inhalational Sulfur Mustard exposure under a joint screening core operated by the BARDA Chemical Medical Countermeasures (Chem MCM) Program and the NIH/NIAID
Chemical Countermeasures Research Program (CCRP).
Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola.
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.
Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in Microorganisms.
Opaganib has received several orphan-drug designations from the FDA in oncology and other diseases 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 also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults3.
RedHill’s key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting,
host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized
COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic
preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also
targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a
Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities,
stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes,"
"hopes," "potential" or similar words and include among others, statements regarding the potential effects of opaganib in the treatment of Ebola and other indications. Forward-looking statements are based on certain assumptions and are subject to
various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company’s ability to maintain compliance with the Nasdaq Capital Market’s listing requirements; the risk that the addition of
new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or
successful; the risk that the FDA does not agree with the Company’s proposed development plans for opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials;
the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be
successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107’s late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3
study, and that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that
additional COVID-19 studies for opaganib and RHB-107 are likely to be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress
and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or
develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the
detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings,
approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and
Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and
commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials;
(ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its
therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company;
(xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access
Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may
affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All
forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information,
future events or otherwise unless required by law.
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
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Category: R&D
1 https://www.who.int/news-room/fact-sheets/detail/ebola-virus-disease
2 Opaganib is an investigational new drug, not available for commercial distribution.
3 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
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