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By Meg Flippin, Benzinga
A decade after a deadly ebola outbreak that left more than 11,000 people dead and only six years after another outbreak killed over 2,000, more needs to be done to find an effective treatment for this infectious disease. That’s what RedHill Biopharma Ltd. (NASDAQ: RDHL), a specialty biopharmaceutical company, is seeking to do with its novel, potentially broad-acting, host-directed therapy, opaganib, a first-in-class new chemical entity with anti-inflammatory, anti-cancer and antiviral activity.
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), just selected opaganib for further development to treat exposure to Ebola virus disease (EBOV). To date, RedHill Biopharma said opaganib has made positive 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 the U.S. Food and Drug Administration’s (FDA) approval of new drugs when human clinical trials are not ethical or feasible.
New Treatments Needed
Ebola is a rare and often deadly virus 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. Currently, only Inmazeb, a combination of three monoclonal antibodies and Ebanga, a single monoclonal antibody, are FDA-approved to treat EBOV. Both are intravenously administered.
According to RedHill Biopharma, there is an urgent need for host-directed small molecule therapies that may be effective against multiple strains of ebolavirus, are less likely to be impacted by viral mutation and are easy to store, distribute and administer, especially in areas where healthcare services and infrastructures may be sub-optimal. With ebola cases predicted to grow in the years to come, driven by a lack of effective treatment, so is the market size for vaccines and treatments. According to one forecast, the ebola drug and vaccine market is poised to reach $223.7 million by 2027, growing at a CAGR of 12.8% from 2022 to 2027.
Opaganib, which is orally administered, is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis and the disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).
BARDA To Provide Funding
Under the cost-sharing agreement with BARDA, BARDA will provide funding to further advance opaganib to mitigate infections and contain EBOV outbreaks. In an in vivo EBOV study with the United States Army Medical Research Institute of Infectious Diseases, RedHill Biopharma said opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day. RedHill Biopharma said it’s the first host-directed molecule to show activity in EBOV.
What’s more, RedHill said opaganib also recently demonstrated a distinct synergistic effect when combined individually with the COVID-19 antiviral treatment remdesivir, significantly improving potency while maintaining cell viability.
“EBOV is deadly, killing, on average, half of all those who contract it. This year marks ten 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 usable treatment strategies,” said Guy Goldberg, RedHill’s Chief Business Officer. “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.”
Fighting More Than EBOV
In addition to EBOV, RedHill said opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants and several other viruses, including Influenza A. 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.
RedHill Biopharma’s novel drug has also been selected for evaluation by other NIH-funded U.S. government countermeasure programs including the Radiation and Nuclear Countermeasures Program (RNCP) for development as a potential treatment for Acute Radiation Syndrome (ARS) and by the BARDA Chemical Medical Countermeasures (Chem MCM) Program and the NIH/NIAID Chemical Countermeasures Research Program (CCRP), in addition to several other U.S. government and non-government collaborations.
Ebola is a fast-spreading and often deadly disease that needs better solutions. RedHill Biopharma and BARDA are betting on opaganib to potentially provide another easier-to-mobilize option to fight outbreaks. To learn more about RedHill Biopharma’s novel drug, click here.
Featured photo by CDC on Unsplash.
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