TIXiMED Expands Program-Related Investment from the Helmsley Charitable Trust to Advance T1D Therapy Development
TIXiMED, Inc., a clinical-stage pharmaceutical company focused on developing innovative therapies for diabetes, has announced an expansion of its program-related investment (PRI) from The Leona M. and Harry B. Helmsley Charitable Trust. The additional funding will support the continued development of TIX100, the company’s investigational oral therapy designed to improve beta cell survival and function in people living with Type 1 Diabetes (T1D).
The newly expanded investment provides TIXiMED with an additional $2.2 million in the form of a loan. This funding will help advance the company’s ongoing clinical research, including a multiple ascending dose (MAD) Phase 1b clinical trial and long-term toxicology studies for TIX100. These studies are considered important milestones in the drug development process and are expected to bring the therapy closer to Phase 2 clinical trials involving patients with Type 1 Diabetes.
The Helmsley Charitable Trust initially provided TIXiMED with a $2.65 million program-related investment in December 2024. That earlier funding enabled the company to successfully conduct and complete its Phase 1a single ascending dose (SAD) clinical study. Results from that study indicated that TIX100 was safe and well tolerated in healthy participants. In addition to demonstrating safety, researchers also observed early metabolic signals that suggested the therapy may have promising potential for improving outcomes in diabetes.
With the new $2.2 million investment, the Helmsley Charitable Trust’s total commitment to TIXiMED now reaches $4.85 million. This expanded support reflects the trust’s continued interest in advancing innovative approaches that could improve the lives of people living with Type 1 Diabetes.
TIX100 works by targeting thioredoxin-interacting protein (TXNIP), a key molecular factor believed to contribute to the dysfunction and death of pancreatic beta cells. Beta cells are responsible for producing insulin, the hormone that regulates blood sugar levels in the body. In people with Type 1 Diabetes, the immune system attacks and destroys these cells, making insulin therapy necessary for survival.
By focusing on TXNIP, TIX100 aims to address one of the underlying biological drivers of beta cell damage. If successful, the therapy could represent a disease-modifying treatment rather than simply managing blood glucose levels through insulin replacement. This approach has the potential to help preserve or restore beta cell function, which could significantly improve long-term outcomes for individuals with T1D.
Stephen Daly, Chief Executive Officer of TIXiMED, expressed appreciation for the continued support from the Helmsley Charitable Trust. He emphasized that the additional funding will help accelerate the company’s clinical development program and move the therapy closer to testing in people living with the disease.
“We are deeply appreciative of the ongoing interest and support from the Helmsley Charitable Trust as we advance our TIX100 program,” Daly said. “This additional funding brings Helmsley’s total commitment to $4.85 million and allows us to conduct the multiple ascending dose trial while completing the necessary long-term toxicology studies. These steps are essential for positioning the program for future clinical evaluation in individuals with Type 1 Diabetes. Our goal is to deliver a transformative oral therapy that targets one of the root causes of beta cell loss.”
Representatives from the Helmsley Charitable Trust also highlighted the importance of supporting innovative research in the field of diabetes. The organization has long focused on initiatives aimed at improving treatment options, care delivery, and quality of life for people with Type 1 Diabetes.
Dr. Ben Williams, Program Officer for the Type 1 Diabetes Program at the Helmsley Charitable Trust, noted that TIXiMED’s progress in developing TIX100 aligns with the organization’s mission to support promising scientific approaches that could bring meaningful advances to the T1D community.
“TIXiMED continues to make encouraging progress in developing TIX100 as a potential first-in-class disease-modifying therapy for Type 1 Diabetes,” Williams said. “Our support reflects our commitment to advancing innovative solutions that could meaningfully improve the lives of people living with this condition.”
Dr. Anath Shalev, Founder and Chief Scientific Officer of TIXiMED, also underscored the significance of the expanded investment. She explained that the funding will enable the company to build on the promising findings from the earlier Phase 1a study and move forward with the next stages of clinical development.
“This continued support from the Helmsley Charitable Trust allows us to further advance TIX100 as a potential first-in-class oral therapy for Type 1 Diabetes,” Shalev said. “The positive safety profile and early metabolic signals observed in our single ascending dose study provide a strong foundation. By progressing to the multiple ascending dose phase and completing long-term toxicology studies, we are taking critical steps toward developing a therapy that could make a meaningful difference for patients.”
As TIXiMED continues its research and development efforts, the expanded investment from the Helmsley Charitable Trust represents an important step toward advancing new treatment possibilities. If successful, TIX100 could offer a novel approach that goes beyond traditional insulin therapy by addressing key mechanisms involved in the progression of Type 1 Diabetes.
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