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BETHESDA, Md.—Late January saw the National Institutes of Health (NIH) announce three new preclinical projects as part of the Bridging Interventional Development Gaps (BrIDGs) program. The projects include efforts to develop a drug to treat acute radiation syndrome, develop treatment for the rare blood disorder beta thalassemia and explore a treatment method to combat cardiac arrest-induced acute brain injury.
The BrIDGs program is led by NIH’s National Center for Advancing Translational Sciences (NCATS) and is funded by the NIH Common Fund. The program provides eligible scientists with access to contractor services at no cost for preclinical therapeutic development. The program primarily benefits small-business and academic research projects that require outside expertise or other resources.
The BrIDGs program is modeled after the National Cancer Institute’s Rapid Access to Institutional Development (RAID) program, and was originally called the NIH RAID program. Often, investigators applying for BrIDGs resources need additional funding or expertise but lack sufficient data to attract third-party investors. Rather than funding projects directly, BrIDGs links the researchers to expert NIH contractors who perform preclinical services free of charge.
“As an institute, we are a highly collaborative organization that allows small businesses and academia access to the experts and tools they need,” says John McKew, acting scientific director for NCATS.
Base funding for the BrIDGs program is fixed, and supports roughly three to four projects annually. Three applications were accepted from 2013’s field of candidates.
A project from Terapio Corp. in Austin, Texas, aims to manufacture a treatment for acute radiation syndrome, a life-threatening multiorgan condition stemming from exposure to radiation. The drug, RLIP76-LyoPL, is designed to be administered 24 hours or longer after a patient is exposed to radiation, making it potentially useful in treating the long-term radiation effects after a nuclear meltdown or nuclear weapon explosion. Currently, no treatments for the acute radiation syndrome are approved by the U.S. Food and Drug Administration (FDA). The Radiation Nuclear Countermeasures Program from the NIH’s National Institute of Allergy and Infectious Diseases is providing co-funding for the preclinical studies.
Another project, from Merganser Biotech in Newtown Square, Pa., will attempt to develop a treatment for beta thalassemia, a rare inherited blood disorder that causes severe anemia and iron overload that may damage the heart. The disorder is characterized by reduced production of the iron regulatory hormone hepcidin, and the project’s goal is the development of minihepcidins that will mitigate the effects of excessive iron in the body. NIH’s National Institute of Diabetes and Digestive and Kidney Diseases will co-fund the project.
Finally, a project from the University of North Carolina at Chapel Hill will work on a formulation called HNB-1, which is designed to combat cardiac arrest-induced acute brain injury. Resuscitation from cardiac arrest can lead to acute brain injury, but lowering a patient’s body temperature into regulated hypothermia and induced coma after cardiac arrest has shown promising rates of patient survival with good neurological outcomes. This project will investigate and evaluate the toxicity of the HBN-1 formulation designed to be administered to cardiac arrest patients intravenously by paramedics to induce hypothermia more quickly. Funding for the preclinical studies for this project is provided by the NIH Common Fund.
Projects accepted into the BrIDGs program represent a broad range of biology and therapeutic modalities, including small molecules, biologics, protein therapeutics and genomics. The eligibility requirements for the program are purposefully somewhat indistinct: The applicant has to be an academic or small business outfit, and the project must have been effective in a disease model. In order to be selected, the researchers must have compelling, quality data sufficient to enable their proposal to pass the rigors of the review process.
“We want to enable everyone to have the opportunity,” says McKew. “These three latest projects are all quite different from one another, and in that sense they’re a microcosm of our portfolio.”
Prior to the most recent round of applications, the BrIDGs program has attracted 274 applications since 2005. It has collaborated on 40 projects, with 21 of these completed to date. So far, 13 BrIDGs program partners have submitted Investigational New Drug applications to the FDA. Seven compounds developed through the BrIDGs program have been licensed by third-party investors.
Although BrIDGs is still a Common Fund project, McKew says his group hopes to make it NCATS-run in the future. In addition, his group continues looking for co-funding from other institutes to help defray costs and to allow funding for more projects in subsequent years. He encourages interested parties to visit www.ncats.nih.gov/bridgs.html for application instructions and more information about the BrIDGs program.
The NIH Common Fund is designed to support emerging high-impact research programs that are broadly relevant to health and disease. The NIH Common Fund supports multidisciplinary, cutting-edge and high-risk/high-reward projects that stand to benefit the biomedical research community at large.