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Anath Shalev, M.D.The University of Alabama at Birmingham startup TIXiMED, Inc., has obtained clearance from the United States Food and Drug Administration to proceed to clinical trials under an Investigational New Drug for TIX100, its novel oral Type 1 diabetes drug. This represents a major milestone in the development of this new approach to T1D treatment and gives TIXiMED the green light to start human studies with TIX100.
The development of TIX100 is based on decades of research by Anath Shalev, M.D., the Nancy R. and Eugene C. Gwaltney Family Endowed Chair in Juvenile Diabetes Research in the UAB Division of Endocrinology, Diabetes and Metabolism in the Department of Medicine and the director of the UAB Comprehensive Diabetes Center.
“Since TIX100 is available orally, it promises to ease the burden of the multiple daily insulin injections or insulin infusions people with T1D depend on,” Shalev said. “We are so excited to see our work being translated into a better diabetes treatment that may impact so many people and provide a breakthrough for T1D.”
Prior to first use in humans, every new drug must be rigorously safety tested. To get IND approval, TIX100 underwent extensive safety pharmacology and toxicokinetics testing as well as elaborate chemistry, manufacturing and control development to ensure an extremely pure, medical-grade drug product for the upcoming clinical trial.
Shalev noted that TIX100 is a potent, effective and specific TXNIP inhibitor and as such functions differently from any approved diabetes drug. By promoting proper islet cell function, it further targets a key underlying cause of the disease.
In diabetes, TXNIP, a protein involved in oxidative stress, is elevated in pancreatic islets and causes beta cell death and dysfunction. Shalev’s research has shown that inhibiting TXNIP protects beta cells and promotes beta cell health and function.
Shalev first identified TXNIP in 2002 in human islets exposed to high glucose and went on to show that it played an important role in glucose toxicity and diabetic beta cell loss.
Over the next two decades, Shalev dug further into the role of TXNIP. The Shalev Lab found that genetic deletion of TXNIP protected against diabetes in different models without causing any detrimental effects. Moreover, non-specific pharmacological TXNIP inhibition not only prevented but also reversed overt diabetes.
These beneficial effects of TXNIP inhibition were illustrated in different mouse models of diabetes as well as in humans with T1D, confirming the translatability of this approach. Using the same preclinical diabetes models, the Shalev Lab was able to test TIX100 and observed even more striking antidiabetic effects. These also included normalization of alpha cell glucagon secretion, a diabetes issue that is difficult to address.
T. Michael Goodrich, II, J.D., president and executive board chair at TIXiMED, Inc., and principal at First Avenue Ventures Life Science, Birmingham, Alabama, says he is very pleased TIXiMED obtained this IND approval from the FDA.
“It is extremely rewarding to see one of our startups reach such an important milestone, and I am confident that the continued success of TIXiMED will serve as a great example of what we can achieve when commercializing a university asset, both from a business perspective and in terms of positively impacting the local and global community,” Goodrich said.
TIXiMED began as a startup in the Bill L. Harbert Institute for Innovation and Entrepreneurship. In 2022, Shalev was awarded the EntrepreHER Award for her three decades of experience in diabetes research and in developing disease-changing therapy regimens, including founding TIXiMED.
“We are overjoyed to hear that the FDA has given TIX100 crucial IND approval and look forward to seeing the results from human clinical trials,” said Kathy Nugent, Ph.D., executive director of the HIIE. “In the world of drug development, this is a significant milestone. We believe in Dr. Shalev’s research and are proud to play a part in its development.”
The UAB Division of Endocrinology, Diabetes and Metabolism in the Department of Medicine and the UAB Comprehensive Diabetes Center are part of the UAB Marnix E. Heersink School of Medicine.