TIXiMED, Inc., a clinical-stage pharmaceutical company, has received a $2.65 million program-related investment from The Leona M. and Harry B. Helmsley Charitable Trust to advance its novel oral therapy, TIX100, into clinical trials. The funding will support a first-in-human, single ascending dose (SAD) study, scheduled to begin in January 2025. TIX100 aims to address the underlying causes of type 1 diabetes (T1D) by targeting TXNIP, offering a potential disease-modifying approach.
Targeting TXNIP for Beta Cell Protection
TIX100 is designed to inhibit thioredoxin-interacting protein (TXNIP), a protein elevated in diabetes that leads to beta cell death and dysfunction. Pre-clinical studies have demonstrated that TXNIP inhibition can protect insulin-producing cells and promote overall islet cell health. TIXiMED recently received FDA Investigational New Drug clearance for TIX100.
"In suppressing TXNIP with TIX100, our aim is to develop a new therapeutic option to promote the patient’s own beta cell survival, insulin production and pancreatic islet health, an approach that is distinct from any currently approved treatments," said Dr. Anath Shalev, TIXiMED founder and Chief Scientific Officer.
Addressing Unmet Needs in Type 1 Diabetes
Type 1 diabetes is an autoimmune disease affecting millions worldwide, characterized by the destruction of insulin-producing beta cells in the pancreas. Current treatments primarily focus on managing blood sugar levels through insulin therapy and lifestyle modifications. TIX100 represents a novel approach by directly targeting beta cell survival and function.
"To date, beta-cell targeted therapies that could treat and delay the progression of T1D are an untapped strategy. Therapies such as TIX100 could fulfill an unmet medical need and improve the lives of people living with T1D," said Dr. Ben Williams, Program Officer at the Helmsley Charitable Trust.
Clinical Trial Plans
The upcoming SAD study will evaluate the safety and tolerability of TIX100 in humans. This trial is a crucial step in assessing the drug's potential as a disease-modifying treatment for T1D. TIX100 is administered orally, offering a convenient alternative to injectable therapies.
"TIXiMED is pleased to receive this significant financial support from the Helmsley Charitable Trust. With it, we are poised to rapidly begin our SAD study in human subjects next month," said the TIXiMED President, Michael Goodrich.
