NCATS is supporting two new Bridging Interventional Development Gaps (BrIDGs) projects selected during the 2014 program application solicitation. Through BrIDGs, NCATS provides scientists with access to pre-clinical drug development resources such as toxicology studies.
One of the new projects is aimed at developing a therapy for diabetic keratopathy, a condition that often leads to blindness. The disease occurs in about one-half to two-thirds of people with diabetes, producing chronic injury and damage to the cornea, the clear outer part of the eye. Diabetic keratopathy frequently is unresponsive to conventional treatments.
The second project is focused on a treatment for ST-segment-elevation myocardial infarction (STEMI), a severe type of heart attack. Each year, approximately 160,000 people in the United States suffer STEMI. Although emergency medical service providers commonly give heart attack victims aspirin and other treatments during transport to the hospital, these interventions are not successful in many cases, and some patients die prior to reaching the hospital.
"The resources NCATS provides through the BrIDGs program — such as to evaluate the safety of candidate therapeutics — can make the difference in whether a promising new treatment reaches clinical trials," said Christopher P. Austin, M.D., NCATS director. "BrIDGs provides a unique and effective path through some of the most difficult phases of translational development."
To be eligible for the BrIDGs program, projects must have been proven effective in a disease model. Researchers often apply to BrIDGs because they have hit a roadblock and need additional expertise or lack other resources. Rather than funding successful applicants directly, BrIDGs operates through collaborative project teams, which provide access to NCATS translational expertise and pre-clinical services contracts at no cost to the collaborating researchers.
A key BrIDGs project goal is to enable the applicant to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to begin human clinical trials. To date, BrIDGs scientists have generated data to support 15 INDs submitted to the FDA, as well as one clinical trial application to Health Canada. Thirteen of the 16 projects have been evaluated in clinical trials. Four BrIDGs-supported therapeutic agents have gone as far as Phase II clinical trials, in which researchers provide an experimental therapy to a group of patients to evaluate its safety and effectiveness. Eight compounds have been licensed to third-party investors for further development during or after their progression through the BrIDGs program.
Posted October 2014