Thetis Pharmaceuticals Receives Orphan Drug Designation for Resolvin E1 Program in Pediatric Ulcerative Colitis
Thetis’ drug candidate TP-317 is a first-in-class small molecule oral therapy in development for inflammatory bowel disease (IBD)
RIDGEFIELD, CT – (December 14, 2020) – Thetis Pharmaceuticals (“Thetis”), a biopharmaceutical company developing novel therapies for autoimmune and inflammatory disorders, announced today that it has received U.S. Food and Drug Administration 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.”
Dr. Jeffrey Hyams, Head of Gastroenterology and Director of the IBD Center at Connecticut Children’s Hospital and a clinical advisor to Thetis, commented, “TP-317 has the potential to address a critical unmet need for safe, oral therapies for children that face a lifetime of chronic illness. I am excited to see the TP-317 program advancing toward clinical investigation.”
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, indicating a unique pharmacological profile compared to approved and other investigational IBD drugs. In addition, Phase 1 studies indicate that RvE1 is safe and well tolerated in healthy volunteers, providing support that TP-317 could offer a favorable safety profile compared to immunosuppressive agents such as biologics and JAK inhibitors.
About Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory bowel disease that mainly affects the large intestine. Symptoms typically include diarrhea mixed with blood, abdominal pain, increased bowel movements and in severe cases, weight loss and fatigue. Children can also develop complications related to growth, development, nutrition, pubertal maturation, bone mineral density accretion and psychological impacts.
Although ulcerative colitis can present at any age, it typically begins in teenagers and young adults. Various studies estimate that there are between 63,000 and 110,000 cases of pediatric ulcerative colitis in the United States, with the majority of these occurring in children aged 10 to 17.
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.
For more information, please visit Thetis Pharmaceuticals’ website (http://thetispharma.com) and follow Thetis on Twitter (@thetispharma).
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