Phase 1a Results Highlight TP-317’s Safety, Tolerability, and Target Engagement

Phase 1b Trial Planned for 2025

January 09, 2025 07:00 AM Eastern Standard Time

ESSEX, Conn.–(BUSINESS WIRE)–Thetis Pharmaceuticals LLC (“Thetis”), a clinical-stage company developing TP-317, a first-in-class, small molecule drug candidate targeting the BLT1 receptor to treat inflammatory bowel disease (IBD), Crohn’s disease and ulcerative colitis, today announced that the company has secured an additional $8.975 million in program-related investment funding in the form of a loan from The Leona M. and Harry B. Helmsley Charitable Trust (“Helmsley”), bringing Helmsley’s total program-related investment in support of oral applications of TP-317 as a potential therapy for Crohn’s Disease patients to $14,044,660. The newly approved funding will support a Phase 1b trial of TP-317 in ulcerative colitis patients to identify safe and efficient dosing.

“Helmsley has been remarkable in supporting our vision for a novel approach that addresses a critical unmet medical need in IBD”Post this

Current treatment options for patients with Crohn’s disease, ulcerative colitis, and IBD fall short, with only a minority of patients achieving lasting remission. Effective therapy requires not only reducing inflammation but also actively repairing the intestinal lining to shield underlying tissues from harmful microbes and pro-inflammatory triggers. No currently approved therapy effectively addresses both therapeutic goals to achieve sustained remission. TP-317 is a proprietary compound of Resolvin E1 (RvE1), a naturally occurring lipid that engages the LTB4-BLT1 pathway to control inflammation and promote intestinal barrier integrity without compromising the body’s natural ability to fight infection.

“The Crohn’s Disease Program at Helmsley is dedicated to addressing the needs of people living with the disease by championing research and technologies that will improve care and treatment,” said Jessica Langer, Ph.D., Program Officer at Helmsley. “With a previous program-related investment in the form of a loan from Helmsley, Thetis successfully completed a Phase 1a study in healthy volunteers, demonstrating the favorable safety, tolerability, and pharmacokinetic profiles of TP-317. In this next phase, we hope to see evidence that TP-317 could expand treatment options and improve quality of life for people with IBD, including people with Crohn’s disease.”

“TP-317 offers a unique barrier protective mechanism that distinguishes TP-317 from existing therapies, with the potential to help IBD patients without the side effects associated with immune suppression,” said Bruce E. Sands, MD, MS, the Dr. Burrill B. Crohn Professor of Medicine, Icahn School of Medicine at Mount Sinai. Dr. Sands, a paid clinical advisor to Thetis, is also Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Mount Sinai Health System.

“Helmsley has been remarkable in supporting our vision for a novel approach that addresses a critical unmet medical need in IBD,” said Gary Mathias, Co-Founder and Chief Executive Officer of Thetis. “We greatly appreciate their support and are excited to advance this unique therapy into patient studies.”

About Thetis Pharmaceuticals
Thetis is a clinical-stage pharmaceutical company focused on developing innovative treatments for chronic inflammatory diseases and cancer. Its lead candidate, TP-317, is a first-in-class oral RvE1 drug candidate that targets the LTB4-BLT1 pathway to mobilize the body’s natural ability to resolve disease and restore immune homeostasis. For more information, please visit www.thetispharma.com, and follow us on LinkedIn.

Contacts

Thetis
Tracy Lessor
TLOW Communications, LLC
617-519-9827
tracy@tlowcommunications.com

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