Thetis Pharmaceuticals Completes Pre-IND Meeting with FDA for its first-in-class Resolvin E1 Candidate, (1/20/2021)
RIDGEFIELD, CT – (January 20, 2021) – Thetis Pharmaceuticals (“Thetis”), a biopharmaceutical company developing novel therapies for autoimmune and inflammatory disorders, announced today that it completed a Pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration for its lead candidate, TP-317, a Resolvin E1 oral, small molecule therapy being developed for inflammatory bowel disease (IBD). FDA has provided guidance on Thetis’ nonclinical and clinical plans, including its proposed Phase 2a clinical trial in ulcerative colitis patients.
“This Pre-IND meeting with FDA 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.”
Dr. William Sandborn, Head of Gastroenterology and Director of the IBD Center at University of California, San Diego and a clinical advisor to Thetis, commented, “TP-317 has the potential to address a critical unmet need for safe, oral therapies for IBD patients with a differentiated, non-immunosuppressive mechanism of action focused on mucosal healing. I am excited to see the TP-317 program advancing toward clinical investigation.”
About TP-317
The active agent in TP-317 is Resolvin E1 (RvE1), an endogenous immunoresolvent discovered by biomedical researchers at Harvard Medical School. When administered therapeutically in preclinical models of IBD, RvE1 activates multiple pathways to resolve inflammation and promote tissue repair without compromising the host’s ability to fight infection. Based on its unique, non-immunosuppressive mechanism of action, TP-317 is differentiated from approved and investigational IBD drugs currently in development. Phase 1 studies indicate that oral RvE1 is safe and generally well tolerated in healthy volunteers. Thetis plans to submit an IND application in 2021 to begin clinical investigation of TP-317.
About Inflammatory Bowel Disease
IBD is a chronic autoimmune disease characterized by inflammation and ulceration of the intestines that includes ulcerative colitis and Crohn’s Disease. Symptoms typically include diarrhea mixed with blood, abdominal pain, increased bowel movements and in severe cases, weight loss and fatigue. Currently available medications alleviate inflammation and reduce symptoms, but do not provide a cure or prevent long-term complications, and some have serious adverse effects, including increased risk of severe infection and malignancy. As a result, there continues to be a high unmet medical need for additional oral agents that are safe and effective for the induction and maintenance of remission of ulcerative colitis and Crohn’s disease.
About Thetis Pharmaceuticals
Thetis is a biopharmaceutical company dedicated to improving the lives of patients suffering from inflammatory diseases. Thetis’ proprietary HEALER™ technology platform enables the pharmaceutical development of Resolvins, a class of endogenous lipid mediators that promote inflammation resolution and tissue repair. Thetis’ HEALER™ technology overcomes the stability, manufacturing, and formulation hurdles that have limited the development of Resolvins as pharmaceutical agents, unlocking their robust pharmacology to be developed as first-in-class drugs with composition of matter patent protection.
For more information, please visit Thetis Pharmaceuticals’ website (http://thetispharma.com) and follow Thetis on Twitter (@thetispharma).
Contact Information
Aaron Mathias
Senior Director of Business Development
amathias@thetispharma.com