The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium launched a research collaboration that aims to remove obstacles to developing antibacterial treatments for common, serious skin infections, and community-acquired bacterial pneumonia (CABP).
Acute bacterial skin infections are increasingly caused by bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), for which only a handful of effective oral medications are available.
The collaboration brings together scientists from the U.S. Food and Drug Administration (FDA), the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Nursing Research, the Infectious Diseases Society of America, pharmaceutical and biotechnology companies, and the academic research community to develop new regulatory standards for judging the efficacy of antibiotics in future clinical trials of therapies for skin infections and CABP.
A challenge in obtaining new antibiotic drug approvals is that the endpoints that FDA uses to judge the success of non-inferiority clinical trials in the infections are based on research studies that date back half a century or more. As a result, FDA approval of new drugs for the infections has been seriously hampered, discouraging pharmaceutical and biotechnology companies from continuing to invest in new antibiotic development efforts.
The FNIH scientific team has assembled and analyzed historical studies and data from modern clinical trials, and submitted recommendations regarding interim clinical trial endpoints to the FDA. The interim recommendations will facilitate clinical drug development programs being conducted now; a second phase plans to further refine the understanding of the endpoints and develop and test new methods for measuring them.
Scientific and financial contributions in support of this project have been provided by Actelion Pharmaceuticals, AstraZeneca, Basilea Pharmaceutica International, Cempra Pharmaceuticals, Cerexa Inc., a wholly-owned subsidiary of Forest Laboratories, Inc., Cubist Pharmaceuticals, Merck, Nabriva Therapeutics and Trius Therapeutics, Inc. Clinical trial data were also contributed to the collaboration by Cerexa and Cubist, as well as by Durata Therapeutics and Pfizer, Inc.
Release Date: Feb. 7, 2012
Source: Foundation for the National Institutes of Health