Soligenix won a contract valued at up to $26.3 million by the Biomedical Advanced Research and Development Authority (BARDA) for the advanced preclinical and manufacturing development of OrbeShield™ (oral beclomethasone 17,21-dipropionate or oral BDP) as a medical countermeasure (MCM) for the treatment of gastrointestinal acute radiation syndrome (GI ARS). The total award will support the preclinical and manufacturing development activities necessary to successfully navigate and complete the FDA approval process for use of OrbeShield to treat GI ARS. The potential five-year contract contains a two-year base period, with two contract options that would extend the contract an additional three years.

OrbeShield is formulated for oral administration in GI ARS patients as a single product consisting of two tablets: One tablet releases BDP in the proximal portions of the GI tract, and the other tablet releases BDP in the distal portions of the GI tract. The FDA has cleared the IND application for OrbeShield for the mitigation of morbidity and mortality associated with GI ARS and also granted OrbeShield orphan drug and fast-track designations for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

BARDA is strengthening its defenses against ARS on other fronts, too: Earlier this week, they exercised $6 million in additional contract options under its advanced research and development contract with Aeolus Pharmaceuticals for AEOL-10150 as a treatment for the pulmonary syndrome of acute radiation syndrome (Lung-ARS) and delayed effects of acute radiation exposure (DEARE).

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