RedHill Biopharma Ltd. recently announced the United States Patent and Trademark Office (USPTO) has issued a patent covering RedHill’s proprietary experimental therapy for the treatment of Ebola virus disease. The patent is expected to be valid until 2035.
As part of RedHill’s research collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH), the company successfully completed a proof-of-concept study to evaluate its proprietary experimental therapy for the treatment of Ebola virus disease. The study evaluated survival outcomes and assessed disease severity through the comparison of viral loads in active treatment arms and placebo.
Results from the proof-of-concept study demonstrated a statistically significant difference in survival outcomes of the active arm versus placebo arm. In light of the results, RedHill intends to further advance the development program for the treatment of Ebola virus disease and has applied for additional support from the Office of Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health & Human Resources to fund a second study to evaluate the potential efficacy of its proprietary experimental therapy.
If successful, this study is intended to provide supportive data for discussions with the US FDA for the 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.
Ebola virus disease is a severe and often fatal illness that can cause severe hemorrhagic fever in humans and has a mortality rate ranging from 25% to 90%. There is currently no FDA-approved treatment for the Ebola virus disease.
RedHill Biopharma Ltd. is a specialty biopharmaceutical company, primarily focused on the development and commercialization of late clinical-stage, proprietary drugs for the treatment of gastrointestinal diseases. For more information, visit www.redhillbio.com.
