Thetis Pharmaceuticals has received an FDA orphan drug designation for TP-317 as a small molecule, oral therapy for treatment of pediatric ulcerative colitis.
“We are pleased that the FDA has granted orphan drug designation for TP-317 for treatment of pediatric ulcerative colitis, highlighting the medical need for new therapeutic options for this patient population,” said Gary Mathias, CEO of Thetis. “Based on encouraging preclinical efficacy and Phase 1 safety data, we believe that TP-317 could offer a major benefit before escalation to biologics or as adjunct to biologics.”