- Phase 1b Multiple Ascending Dose (MAD) Study to Evaluate Safety, Tolerability, and Pharmacokinetics of an Investigational Oral Disease-Modifying Type 1 Diabetes Therapy
- Study Builds on Phase 1a Single Ascending Dose Results Demonstrating Safety, Tolerability, and First Metabolic Signal of TIX100 in Humans
BIRMINGHAM, Ala.--(BUSINESS WIRE)--#T1D--TIXiMED, Inc. (www.TIXiMED.com), a clinical-stage pharmaceutical company developing a novel disease-modifying oral therapy for type 1 diabetes (T1D), today announced the initiation of the Phase 1b Multiple Ascending Dose (MAD) study of TIX100 (NCT07675590), an investigational oral inhibitor of thioredoxin-interacting protein (TXNIP).
The TIX100 MAD study is a double-blind, randomized, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of orally administered TIX100. The study will enroll 18 healthy subjects across three ascending dose cohorts at a single US center, with each cohort receiving TIX100 or placebo twice daily for 28 days, followed by a seven-day follow-up.
The study follows the successful completion of the Phase 1a Single Ascending Dose study, in which TIX100 was found to be safe and well tolerated across all four dose cohorts, produced no hypoglycemia even during extended fasting, and lowered postprandial glucose excursion in a healthy, normoglycemic population, the first metabolic signal of TIX100 in humans. The current trial is further supported by favorable results from expanded pharmacokinetics and safety pharmacology studies as part of the large Investigational New Drug package approved by the U.S. Food and Drug Administration.
“Over two decades, our research has established TXNIP as a key driver of pancreatic islet beta cell loss and diabetes progression. TIX100 now provides a clinical translation of these biological findings. The single-dose study gave us a first, encouraging metabolic signal in humans, and the MAD study will generate the longer-term safety data we need before advancing into a Phase 2a study including people with recent-onset type 1 diabetes,” said Anath Shalev, MD, Chief Scientific Officer and Co-Founder of TIXiMED.
The development of TIX100 is based on decades of research that identified the detrimental protein TXNIP as a therapeutic target in human pancreatic islets. TXNIP is elevated in diabetes and leads to beta cell loss, whereas inhibiting it protects the body’s own insulin producing beta cells and promotes overall islet cell health. This has been demonstrated in different mouse models of diabetes as well as in humans with T1D. TIX100 is orally available, targets the underlying causes of the disease, and in preclinical studies has shown promising effects on T1D.
"Each milestone we reach brings a differentiated oral approach for type 1 diabetes closer to the patients who need it. People at different stages of type 1 diabetes, from those at risk to those living with long-standing disease, still have no oral options or therapy designed to address the underlying damage to islet biology, and that is the gap we are working to close," said Stephen Daly, Chief Executive Officer of TIXiMED.
“The Helmsley Charitable Trust is committed to supporting therapies that have the potential to change the course of type 1 diabetes,” said Ben Williams, Ph.D., Program Officer, Type 1 Diabetes Program at The Leona M. and Harry B. Helmsley Charitable Trust. “The progress TIXiMED has made into multiple-dose clinical evaluation reflects the kind of disciplined, science-driven development we are pleased to support through our Program Related Investments.”
About TIXiMED, Inc.
TIXiMED is a clinical-stage pharmaceutical company dedicated to developing and commercializing a first-of-its-kind oral TXNIP inhibitor, TIX100. TIX100 targets underlying mechanisms of diabetes and metabolic disease by protecting beta cells and improving whole body glucose control as well as addressing related metabolic conditions. TIXiMED is currently advancing the clinical development of TIX100 for diabetes and additional metabolic indications. For more information, visit www.tiximed.com.
The Helmsley Charitable Trust made a Program Related Investment in the form of a loan to support this project.
Contacts
Stephen Daly
Chief Executive Officer
steve@tiximed.com
