Soligenix, Inc., a development stage biopharmaceutical company, has received the “Fast Track” designation from the US Food and Drug Administration (FDA) for its OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP) development programme for the treatment of gastrointestinal acute radiation syndrome (GI ARS).

Soligenix has also previously received Orphan Drug designation from the FDA for oral BDP for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for OrbeShield on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of six months.

“There are no FDA approved therapies for the treatment of GI ARS,” stated Christopher J Schaber, PhD, president & chief executive officer of Soligenix. “The FDA's action in granting fast track designation is a validation of BDP's potential to address this life-threatening, unmet medical need.  We look forward to working closely with the FDA, as well as with the National Institute of Allergy and Infectious Disease (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to potentially expedite the OrbeShield development programme.”

ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs. In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days.  The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI.  Although the hematopoietic syndrome has the potential to be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that results from high-dose radiation exposure. Therefore, there is an urgent need to develop specific medical countermeasures against the lethal pathophysiological manifestations of radiation-induced GI injury.

OrbeShield contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. OrbeShield is formulated for oral administration in GI ARS patients as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract and the other tablet is intended to release BDP in the distal portions of the GI tract.

Soligenix is developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics.