Soligenix, U.S. Department of Health and Human Services other news
HHS's Biomedical Advanced Research and Development Authority (BARDA) awarded Soligenix up to $26.3 million to develop OrbeShield as a medical countermeasure to treat gastrointestinal acute radiation syndrome (GI ARS). Soligenix will receive about $10.6 million for an initial two-year period and up to $26.3 million if the contract is extended for an additional three years.
The company expects the award to support preclinical and manufacturing development as well as activities to complete the FDA approval process. The oral formulation of beclomethasone dipropionate (BDP) is in preclinical development for GI ARS and has Orphan Drug and Fast Track designations to prevent death following a potentially lethal dose of total body irradiation during or after a radiation disaster. Soligenix plans to conduct a Phase I/II trial of the product in healthy adolescent and young adult volunteers following the completion of an ongoing preclinical canine study, from which data are expected in 1H14. ...