Soligenix, Inc., a late-stage biopharmaceutical company, announced that the National Institute of Allergy and Infectious Diseases (NIAID) has exercised its option to advance preclinical development of OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP). The 12-month option provides an additional $2.1 million to Soligenix to advance OrbeShield as a medical countermeasure (MCM) for the treatment of gastrointestinal acute radiation syndrome (GI ARS). NIAID granted the award of up to $6.4 million over three years on September 18, 2013.

Soligenix's GI ARS programme is supported by contract awards from both the Biomedical Advanced Research Development Authority (BARDA) and NIAID, totaling up to approximately $32 million.  In addition to developing oral BDP as a MCM, the company is also pursuing oral BDP as a treatment for GI inflammation in pediatric Crohn's disease and acute radiation enteritis.

"The execution of the second option reflects NIAID's ongoing commitment to developing MCMs for GI ARS and the compelling nature of Soligenix's OrbeShield product," stated Christopher J. Schaber, PhD, president and chief executive officer of Soligenix. "This continued funding, plus the BARDA contract awarded, has the potential to provide the necessary funding to advance the development of OrbeShield while building upon the scientific evidence supporting its use as a potential MCM in GI ARS.  We thank NIAID for their past and present support and look forward to continuing our close collaboration as we advance this technology."

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, people exposed to radiation levels greater than 2 Gy are at high risk of developing ARS. Exposure to high doses of radiation exceeding 10 to 12 Gy causes acute GI injury, which can result in death in 5 to 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 total body irradiation.  Although hematopoietic ARS can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that occurs after high-dose radiation. Therefore, there is an urgent need to develop specific MCMs against the lethal consequences of radiation-induced GI injury.

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.  BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of allergic rhinitis and asthma. To date, oral BDP has been safely administered to more than 350 human subjects in multiple clinical studies.  Oral BDP is also being developed for use in other GI disorders characterized by severe inflammation such as pediatric Crohn's disease and radiation enteritis.

The FDA has cleared the Investigational New Drug (IND) application for OrbeShield for the mitigation of morbidity and mortality associated with GI ARS.  OrbeShield has also been granted Orphan Drug and Fast Track designations by the FDA for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.  OrbeShield development as an MCM for GI ARS is currently being supported by BARDA and NIAID contracts valued up to $26.3 million and $6.4 million, respectively.

Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense.