RedHill Biopharma in research collaboration with NIH for potential Ebola treatment

Israel’s RedHill Biopharma (TASE: RDHL) has signed a research collaboration agreement with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), intended to evaluate RedHill’s proprietary experimental therapy for the treatment of Ebola virus disease.

The new research collaboration follows encouraging results from preliminary non-clinical studies conducted in conjunction with the NIAID using RedHill’s proprietary experimental therapy. The objectives of the new research collaboration between RedHill and the NIAID are to evaluate survival outcome and assess disease severity through comparison of viral loads and cytokine levels in active treatment arms and placebo.

If successful, this study is intended to provide supportive data for discussions with the US Food and Drug Administration for potential use of the Animal Rule pathway for approval. According to FDA guidelines, approval under the Animal Rule can be pursued only if human efficacy studies cannot be conducted because the conduct of such trials is unethical or not feasible.