Soligenix, Inc., a clinical stage biopharmaceutical company, has been awarded a contract valued at up to $26.3 million by the US Department of Health and Human Service's Biomedical Advanced Research and Development Authority (BARDA). The contract is for the advanced preclinical and manufacturing development of OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP) as a MCM for the treatment of gastrointestinal acute radiation syndrome (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. 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.
"Securing a highly competitive BARDA contract provides important recognition as to the innovative quality and potential therapeutic impact of our technology," stated Christopher J Schaber, PhD, president & chief executive officer of Soligenix. "This contract award provides the comprehensive funding necessary to continue development of OrbeShield while building upon the growing body of compelling scientific evidence supporting its use as a potential MCM for GI ARS. We thank BARDA for their support and look forward to collaborating closely with them 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, 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 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 pathophysiological manifestations 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 patients with 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 in other GI disorders characterized by severe inflammation such as pediatric Crohn's disease, radiation enteritis and chronic Graft-versus-Host disease (cGVHD).
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.
The BARDA within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services, provides an integrated, systematic approach to the development and procurement of critical products needed for public health emergencies.