FDA gives Soligenix IND clearance for GI-ARS drug

Soligenix, Inc., a Princeton, N.J.-based biopharmaceutical company, announced on Sunday that the U.S. Food and Drug Administration reviewed and approved its investigational new drug application for its gastrointestinal acute radiation syndrome drug.

OrbeShield, oral beclomethasone 17,21-dipropionate or oral BDP, mitigates morbidity and mortality connected with GI-ARS. The company previously received orphan drug designation for oral BDP to prevent death following a potentially lethal dose of total body irradiation after or during a radiation incident.

"We are very excited to advance the development of OrbeShield, which we believe has the potential to be a safe and effective medical countermeasure in the event of a nuclear attack or radiation accident," Kevin Horgan, Soligenix's senior vice president and chief medical officer, said. "We believe our proprietary two-tablet system has the pharmacological, clinical and manufacturing attributes necessary to potentially provide a substantial contribution to our national defense response systems so that we are optimally prepared in the event of a public health emergency such as (a) nuclear accident or terrorist attack."

The IND clearance of OrbeShield gives Soligenix the ability to initiate a development program that will include preclinical safety and efficacy evaluations and a Phase 1 and 2 pharmacodynamic/pharmacokinetic study of the drug. Soligenix will use the data from the studies to inform dosing information from animal studies for human patients.

Soligenix is developing countermeasures as part of the Biomedical Advanced Research and Development Authority Strategic Plan of 2011-2016. Approved countermeasures will be included in the U.S. Strategic National Stockpile. The company's lead development products for biodefense include a ricin countermeasure and an anthrax exposure vaccine.