Clinical Trial Shows Promising Results for Novel Diabetes Therapy
BIRMINGHAM, Alabama – May 28, 2025 – TIXiMED, a clinical-stage biotechnology company spun out of the University of Alabama at Birmingham (UAB), today announced positive results from its Phase 1 Single Ascending Dose (SAD) study of TIX100, a novel oral therapy targeting thioredoxin-interacting protein (TXNIP) for the treatment of diabetes. The investigational drug demonstrated a favorable safety profile and produced the first evidence of biological activity in humans, marking a critical milestone in developing a disease-modifying treatment for both Type 1 and Type 2 diabetes.
The randomized, double-blind, placebo-controlled trial evaluated TIX100 in 28 health adult volunteers across escalating dose levels. Results showed the drug was well-tolerated with no drug-related adverse events, no hypoglycemia, and no clinically significant electrocardiogram changes. Post-hoc analysis revealed decreased post-meal blood glucose excursion in the two highest dose cohorts, suggesting TIX100 may improve glucose homeostasis even in non-diabetic subjects. These findings align with extensive preclinical research demonstrating TIX100’s ability to protect pancreatic islet cells and enhance insulin secretion. For more details on the study’s methodology and complete findings, refer to the official trial summary published by UAB’s Comprehensive Diabetes Center .
TIX100 represents a fundamental departure from existing diabetes treatments by targeting TXNIP, a protein that becomes elevated in diabetes and drives beta-cell apoptosis, glucagon excess, and islet dysfunction. Unlike GLP-1 receptor agonists that require weekly injections and can cause significant gastrointestinal side effects, TIX100 is an oral, small-molecule therapy designed to address the underlying pathophysiology of diabetes while preserving lean muscle mass. Preclinical studies in multiple animal models showed TIX100 prevented and reversed diabetes, reduced HbA1c by up to 2.3%, and protected against obesity-associated glucose intolerance without aggressive weight loss.
“The completion of our Phase 1 study with such a clean safety profile and early metabolic signals validates our hypothesis that targeting TXNIP could revolutionize diabetes care,” said Dr. Anath Shalev, MD, Director of the UAB Comprehensive Diabetes Center, discoverer of the TXNIP pathway, and co-founder of TIXiMED. “For patients who fear needle-based therapies or cannot tolerate existing injectable options, TIX100 offers hope for an oral medication that treats the root cause rather than just the symptoms.”
The global diabetes therapeutics market reached $76.75 billion in 2023 and is projected to surge to $321.96 billion by 2033, expanding at a compound annual growth rate of 15.4%, according to industry analysis. Despite this growth, significant unmet needs persist. Approximately 8.4 million Americans rely on insulin therapy, yet many struggle with adherence to multiple daily injections. The Type 1 diabetes market alone was valued at $5.9 billion across major markets in 2024, with limited disease-modifying options available. TIX100’s oral delivery and novel mechanism position it to capture a substantial share of patients seeking alternatives to injectable therapies.
Building on these results, TIXiMED is initiating a Phase 1 Multiple Ascending Dose (MAD) study to assess longer-term safety and pharmacokinetics, with plans to advance directly to Phase 2 trials in Type 1 diabetes patients later this year. The company secured $2.65 million in program-related investment from the Leona M. and Harry B. Helmsley Charitable Trust and early-stage support from Innovate Alabama’s InvestAL venture program to accelerate development.
“The diabetes landscape is dominated by incremental improvements to existing drug classes,” said Michael Goodrich, CEO of TIXiMED. “TIX100 has the potential to become the first oral disease-modifying therapy for Type 1 diabetes, addressing a market that has seen virtually no innovation in disease etiology since insulin’s discovery a century ago.”
About TIXiMED
TIXiMED is a privately held clinical-stage biotechnology company headquartered in Birmingham, Alabama, focused on developing transformative therapies for diabetes and metabolic diseases. Founded in partnership with UAB’s Comprehensive Diabetes Center, the company is advancing TIX100, a first-in-class oral TXNIP inhibitor that has demonstrated potential to prevent and reverse diabetes in preclinical models and has now completed successful Phase 1 human trials. TIXiMED is supported by strategic investors including the Helmsley Charitable Trust and Innovate Alabama.
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