A Connecticut startup’s experimental treatment for ulcerative colitis in children has been deemed an ‘orphan’ drug by the Food and Drug Administration, making it eligible for financial incentives.
The compound, TP-317, is a naturally occurring lipid discovered by researchers at Harvard Medical School. Early-stage human trials found it to be safe in healthy volunteers.
Thetis Pharmaceuticals has billed it as an alternative to immunosuppressive agents to treat the chronic inflammatory bowel disease, which affects between 63,000 and 110,000 children a year in the United States.
Symptoms include bloody diarrhea, abdominal pain, increased bowel loss and, in severe cases, weight loss and fatigue. Current treatments reduce symptoms but can come with serious side effects.
“TP-317 has the potential to address a critical unmet need for safe, oral therapies for children that face a lifetime of chronic illness,” said Dr. Jeffrey Hyams, director of the IBD Center at Connecticut Children’s Hospital and a clinical advisor to Thetis.
The FDA reserves the ‘orphan’ label for drugs that treat rare diseases. Companies developing such drugs are eligible for tax credits, fee waivers and a period of market exclusivity after the drug is approved.
Thetis closed its Branford office and went virtual in May as a result of the pandemic, Director of Business Development Aaron Mathias said in an email to New Haven Biz.
It lists its home base as Ridgefield and still has an office at UConn’s Technology Incubation Program (TIP) in Farmington.
Contact Natalie Missakian at news@newhavenbiz.com
