Soligenix said today it was awarded $2.1 million in additional funding from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) after it exercised a second 12-month option to advance preclinical development of OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP) as a medical countermeasure (MCM) for gastrointestinal acute radiation syndrome (GI ARS).

The option is part of an award of up to $6.4 million over three years from NIAID to Soligenix on September 18, 2013. Last year the company won its first 12-month option of $2.1 million.

NIAID’s funding is part of a total of about $32 million awarded to Soligenix for its GI ARS program; the company also won up to $26.3 million from the Biomedical Advanced Research and Development Authority (BARDA) in 2013 toward advanced preclinical and manufacturing development.

“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,” Soligenix president and CEO Christopher J. Schaber, Ph.D., said in a statement. “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.

OrbeShield for GI ARS consists of two tablets: One releases BDP in the proximal portions of the GI tract, while the other releases BDP in the distal portions of the GI tract.  BDP has been marketed in the U.S. and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of allergic rhinitis and asthma.

In addition to developing oral BDP as a MCM, Soligenix is also pursuing oral BDP as a treatment for GI inflammation in pediatric Crohn's disease and acute radiation enteritis.

OrbeShield has received the FDA’s 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. The FDA has also cleared the IND application for OrbeShield for the mitigation of morbidity and mortality associated with GI ARS.

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