A drug being developed by New Haven’s BioXcel Therapeutics to treat a rare cancer of the body’s soft tissue has been granted ‘orphan status’ by the FDA, according to a regulatory filing.
The designation makes the company eligible for financial incentives such as tax credits and reduced regulatory fees. Another benefit is the potential for seven years of market exclusivity.
The Food and Drug Administration granted the designation to BXCL701 to treat soft tissue sarcoma, according to a Jan. 28 Securities and Exchange Commission filing.
The FDA generally grants orphan status to drugs targeting diseases that affect fewer than 200,000 people in the United States.
Soft tissue sarcomas develop in soft tissues like fat, muscle, nerves, fibrous tissues, blood vessels or deep skin tissues, according to the American Cancer Society.
BXCL701 is designed to stimulate both the innate and acquired immune systems.
It works by inhibiting the enzymes dipeptidyl peptidase (DPP) 8/9 and blocking immune invasion by targeting Fibroblast Activation Protein (FAP), according to BioXcel’s website.
BioXcel has already been testing the drug in human trials for aggressive forms of prostate cancer solid tumors.
Contact Natalie Missakian at news@newhavenbiz.com.
