TIXiMED Announces Successful Completion of a Phase 1 Study of its Novel Oral Disease-Modifying Type 1 Diabetes Therapy

Business Wire

29-05-2025

BIRMINGHAM, Ala.--(BUSINESS WIRE)-- 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 successful completion of the Phase 1 Single Ascending Dose (SAD) study for TIX100. This first human trial confirmed that TIX100 was safe and well-tolerated across all tested dose levels in healthy subjects. Additionally, post-hoc analysis revealed decreased postprandial blood glucose excursion and improved glucose homeostasis after a standardized liquid meal in the two highest dose cohorts, providing the first evidence of a biological TIX100 effect in humans.
Building on these results, TIXiMED is now preparing to initiate a Phase 1 Multiple Ascending Dose study to further assess longer-term TIX100 safety, tolerability, and pharmacokinetics over multiple doses in healthy subjects.
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'We are thrilled with the successful completion of the Phase 1 SAD study, which demonstrated the safety and tolerability of TIX100 in humans,' said Dr. Anath Shalev, Founder and Chief Scientific Officer at TIXiMED. 'We are also excited that, despite the small sample size and healthy study population, a promising metabolic TIX100 signal became evident at the human dose predicted in preclinical models,' Dr. Shalev added. 'These findings also suggest that stronger effects might be observed in people with diabetes and bring TIXiMED closer to delivering a novel oral therapy that addresses the underlying causes of T1D, offering hope for improved outcomes for patients across all stages of the disease.'
This double-blind, randomized, placebo-controlled Phase 1 SAD study evaluated the safety, tolerability, and pharmacokinetics of TIX100 at escalating doses in 28 healthy adults. Clinical and laboratory results demonstrated no drug-related adverse events, no ECG changes and no hypoglycemia with TIX100 exhibiting a favorable safety profile and predictable pharmacokinetics, supporting progression to the next phase of clinical development.
TIX100 is an oral drug that targets thioredoxin-interacting protein (TXNIP), a detrimental protein that is elevated in people with diabetes and leads to beta cell death and pancreatic islet dysfunction. TXNIP inhibition has been demonstrated in mouse models and in humans with T1D to protect the body's own insulin-producing beta cells while promoting overall islet cell health. TIX100 has also been shown to reduce unnecessary glucose production from the liver. TIX100 is a potent and specific TXNIP inhibitor designed to target these underlying disease mechanisms and has been shown to be highly efficacious in preventing and reversing diabetes in pre-clinical studies.
Building on these results, TIXiMED is now preparing to initiate a Phase 1 Multiple Ascending Dose (MAD) study to further assess longer-term TIX100 safety, tolerability, and pharmacokinetics over multiple doses in healthy subjects.
'Clinical advancement of innovative therapies addressing the fundamental biological causes of T1D is exciting, and supporting these efforts is critical to preventing and delaying T1D disease progression,' says Dr. Ben Williams, Program Officer at The Leona M. and Harry B. Helmsley Charitable Trust.
'The unique target product profile and mechanism of TIX100 positions it as a promising candidate to transform T1D management,' said Steve Daly, CEO of TIXiMED. 'We are inspired by these results and excited to advance to the MAD study, continuing our mission to address the unmet needs of people living with T1D.'
About TIXiMED
TIXiMED is a pharmaceutical company dedicated to developing and commercializing a first-of-its kind oral therapy for type 1 diabetes based on inhibition of the protein TXNIP. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small molecule TXNIP inhibitor, and its derivatives, which has been shown to protect against models of type 1 and type 2 diabetes as well as metabolic dysfunction–associated steatotic liver disease. Visit www.tiximed.com for more information.
The Helmsley Charitable Trust made a Program Related Investment in the form of a loan to support this project.