Soligenix drug for acute radiation syndrome granted orphan drug designation

Soligenix, Inc., announced on Monday that SGX94, a drug for treating acute radiation syndrome, has been granted orphan drug status by the Food and Drug Administration.

The U.S. Orphan Drug Act was created to assist the development of safe and effective therapies for diseases or disorders that are not common. With orphan status, Soligenix will have a seven year market exclusivity once the FDA makes a final approval of the drug. Soligenix now also has access to a large range of benefits, including government grants for trials, waiver of FDA user fees and certain tax credits.

"The FDA's decision to grant SGX94 orphan drug designation signifies an important step for Soligenix as we continue to expand our biodefense pipeline and the many potential applications of our novel IDR technology," Christopher J. Schaber, the president and chief executive officer of Soligenix, said. "SGX94's activity in preclinical models has demonstrated the potential to mitigate damage to the skin and gastrointestinal tract, as well as enabling clearance of infection as a result of damage to the hematopoietic system, all of which occur with varying severity in ARS. The marketing exclusivity that orphan drug designation imparts adds significantly to the existing patent estate surrounding SGX94."

SGX94 is an innate defense regulator that accelerates the resolution of tissue damage after exposure to numerous agents like bacterial pathogens, trauma, radiation and/or chemotherapy.