A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects

Start Date01 Jan 2025

Sponsor / Collaborator

TIXiMED, Inc.

100 Clinical Results associated with TIX-100

100 Translational Medicine associated with TIX-100

100 Patents (Medical) associated with TIX-100

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01 Apr 2025·Diabetes, Obesity and Metabolism

Oral TIX100 protects against obesity‐associated glucose intolerance and diet‐induced adiposity

Article

Author: Xu, Guanlan ; Jo, SeongHo ; Jing, Gu ; Shalev, Anath ; Chen, Junqin

AbstractAimsGlucagon‐like peptide 1 receptor agonists and dual agonists have changed the treatment landscape of obesity and type 2 diabetes (T2D), but significant limitations have emerged due to their gastrointestinal side effects, loss of lean mass, and necessity for ongoing subcutaneous injections. Our objective was, therefore, to test a novel small molecule as a different and potentially better tolerated oral medications to improve obesity‐associated impairment in glucose homeostasis.Materials and MethodsHigh‐fat diet (HFD)‐fed mice or severely obese, leptin‐deficient ob/ob mice were randomly assigned to serve as controls or receive oral TIX100, a novel thioredoxin‐interacting protein (TXNIP) inhibitor just approved by the FDA as an investigational new drug for type 1 diabetes (T1D). The TIX100 effects on glucose intolerance and weight control were then assessed.ResultsTIX100 protected against HFD‐induced glucose intolerance, hyperinsulinemia, and hyperglucagonemia. TIX100 also reduced diet‐induced adiposity resulting in 15% lower weight in treated mice as compared with controls on HFD (p <0.05), while preserving lean mass. Even though the TIX100 weight effects were lost in ob/ob mice, TIX100 improved glucose control leading to a dramatic 2.3% reduction in HbA1C (p <0.05), independent of any weight loss. This is consistent with the beneficial effects of TIX100 in non‐obese diabetes models and its protection against elevated TXNIP and islet cell stress common to all diabetes types.ConclusionsThus, TIX100 may provide a novel, oral therapy for T2D that targets underlying disease pathology including islet cell dysfunction and hyperglucagonemia and promotes metabolic health and weight control without aggressive weight loss.

Frontiers in Endocrinology

A novel class of oral, non-immunosuppressive, beta cell-targeting, TXNIP-inhibiting T1D drugs is emerging

Review

Author: Jing, Gu ; Jo, SeongHo ; Shalev, Anath

Diabetes treatment options have improved dramatically over the last 100 years, however, close to 2 million individuals in the U.S. alone live with type 1 diabetes (T1D) and are still dependent on multiple daily insulin injections and/or continuous insulin infusion with a pump to stay alive and no oral medications are available. After decades of focusing on immunosuppressive/immunomodulatory approaches for T1D, it has now become apparent that at least after disease onset, this by itself may not be sufficient, and in order to be effective, therapies need to also address beta cell health. This Perspective article discusses the emergence of such a beta cell-targeting, novel class of oral T1D drugs targeting thioredoxin-interacting protein (TXNIP) and some very recent advances in this field that start to address this unmet medical need. It thereby focuses on repurposing of the antihypertensive drug, verapamil found to non-specifically inhibit TXNIP and on TIX100, a new chemical entity specifically developed as an oral anti-diabetic drug to inhibit TXNIP. Both have shown striking anti-diabetic effects in preclinical studies. Verapamil has also proven to be beneficial in adults and children with recent onset T1D, while TIX100 has just been cleared by the U.S. Food and Drug Administration (FDA) to proceed to clinical trials. Taken together, we propose that such non-immunosuppressive, adjunctive therapies to insulin, alone or in combination with immune modulatory approaches, are critical in order to achieve effective and durable disease-modifying treatments for T1D.

100 Deals associated with TIX-100

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