RedHill Biopharma Ltd. announced the signing of a research collaboration agreement with the U.S. 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 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 U.S. Food and Drug Administration (FDA) 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.1
Ebola virus disease is a severe and often fatal illness which can cause severe hemorrhagic fever in humans and has a mortality rate ranging from 25 to 90 percent.2 There is currently no FDA approved treatment for Ebola virus disease.
- Product Development Under the Animal Rule – Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), October 2015.
- World Health Organization (WHO), Fact sheet No° 103, January 2016.
Filed Under: Drug Discovery