Thetis Pharmaceuticals has completed a Pre-IND (Investigational New Drug) meeting with the FDA for its lead candidate, TP-317, a Resolvin E1 oral, small molecule therapy being developed for inflammatory bowel disease (IBD).
“This meeting was a significant milestone for Thetis,” said Gary Mathias, co-founder and CEO of Thetis. “We are pleased to receive guidance from the FDA that we should be able to initiate clinical trials without additional nonclinical toxicology studies, based in part on preclinical and clinical safety data with oral Resolvin E1.”