RedHill Biopharma Receives BARDA Funding to Develop Opaganib as Potential Ebola Treatment

In a significant development for global health preparedness, RedHill Biopharma Ltd. has been awarded funding from the U.S. government's Biomedical Advanced Research and Development Authority (BARDA) to further the development of opaganib as a potential treatment for Ebola virus disease (EBOV). This move comes as the world continues to grapple with the threat of Ebola outbreaks, highlighting the critical need for more effective and accessible treatments.

Opaganib, a first-in-class new chemical entity developed by RedHill Biopharma, has shown promising results in preliminary studies. The drug's unique mechanism of action, which involves inhibiting multiple pathways and disrupting viral replication, positions it as a potentially broad-acting, host-directed therapy. This approach could prove crucial in combating Ebola, a disease that has caused devastating outbreaks in recent years, including one that claimed over 11,000 lives a decade ago.

The significance of this development lies in opaganib's potential to address several key challenges in Ebola treatment. Unlike currently approved therapies that require intravenous administration, opaganib is orally administered, making it potentially easier to distribute and use in areas with limited healthcare infrastructure. Additionally, as a host-directed small molecule therapy, it may be effective against multiple strains of ebolavirus and less susceptible to viral mutations, a critical factor in long-term treatment strategies.

RedHill Biopharma's Chief Business Officer, Guy Goldberg, emphasized the urgent need for such therapies, stating, "There are 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 underscores the potential impact of opaganib not just on Ebola treatment, but on global pandemic preparedness as a whole.

The BARDA funding will support further advancement of opaganib through the Animal Rule pathway, a regulatory approach that allows for the use of animal model efficacy studies to support FDA approval when human clinical trials are not ethical or feasible. This pathway is particularly relevant for diseases like Ebola, where conducting large-scale human trials poses significant ethical and practical challenges.

Opaganib has already shown promising results in preliminary studies. In an in vivo EBOV study conducted with the United States Army Medical Research Institute of Infectious Diseases, the drug demonstrated a statistically significant increase in survival time when administered at 150 mg/kg twice a day. This makes opaganib the first host-directed molecule to show activity against EBOV, marking a potentially significant breakthrough in treatment approaches.

The implications of this development extend beyond Ebola. RedHill Biopharma reports that opaganib has demonstrated antiviral activity against other viruses, including SARS-CoV-2 and Influenza A. The drug is also being investigated for multiple oncology, inflammatory, and metabolic indications. This broad spectrum of potential applications highlights the versatility of opaganib's mechanism of action and its potential impact on various areas of medicine.

As the global healthcare community continues to face challenges from emerging and re-emerging infectious diseases, the development of drugs like opaganib represents a critical step forward. The support from BARDA not only validates the potential of this approach but also underscores the U.S. government's commitment to advancing innovative solutions for global health threats.

The Ebola drug and vaccine market is projected to grow significantly in the coming years, with forecasts suggesting it could reach $223.7 million by 2027. This growth reflects both the ongoing threat posed by Ebola and the increasing focus on developing effective countermeasures. The advancement of opaganib could play a crucial role in shaping this market and, more importantly, in improving global preparedness for Ebola outbreaks.

As RedH