Birmingham, AL — TIXiMED, Inc., a startup emerging from the University of Alabama at Birmingham (UAB), has received crucial clearance from the U.S. Food and Drug Administration (FDA) to advance its innovative oral medication, TIX100, into clinical trials. This milestone marks a significant step forward in the quest for improved treatments for Type 1 diabetes (T1D), allowing the company to begin human trials with its groundbreaking drug.
The development of TIX100 is grounded in extensive research led by Dr. Anath Shalev, M.D., the Nancy R. and Eugene C. Gwaltney Family Endowed Chair in Juvenile Diabetes Research at UAB. Dr. Shalev, who also directs the UAB Comprehensive Diabetes Center, has been at the forefront of research into TXNIP, a protein implicated in diabetes.
“TIX100, being an oral medication, offers a promising alternative to the daily insulin injections or infusions that current T1D patients rely on,” Dr. Shalev said. “We are thrilled to see our research translating into a treatment that could significantly improve the lives of those affected by Type 1 diabetes.”
Before receiving Investigational New Drug (IND) approval, TIX100 underwent rigorous testing for safety, pharmacology, and toxicokinetics. The drug also underwent thorough chemistry, manufacturing, and control development to ensure it meets high purity and quality standards for clinical trials.
Dr. Shalev explained that TIX100 operates as a potent TXNIP inhibitor, distinguishing it from existing diabetes medications. By targeting TXNIP, which contributes to beta cell damage in the pancreas, TIX100 aims to enhance islet cell function and address a core aspect of diabetes pathology. Shalev’s research demonstrated that TXNIP inhibition can protect and improve beta cell health, a discovery initially made in 2002.
The Shalev Lab’s subsequent studies revealed that TXNIP genetic deletion could prevent diabetes in various models, and non-specific TXNIP inhibition could both prevent and reverse diabetes symptoms. These findings, confirmed in mouse models and human trials, underscore the potential of TIX100, which has shown promising antidiabetic effects, including normalizing glucagon secretion.
T. Michael Goodrich, II, J.D., president and executive board chair at TIXiMED, expressed enthusiasm about the FDA’s approval. “Reaching this milestone is immensely rewarding. It exemplifies the potential of commercializing university research to make a global impact,” Goodrich said.
TIXiMED originated from the Bill L. Harbert Institute for Innovation and Entrepreneurship. In 2022, Dr. Shalev was honored with the EntrepreHER Award for her pioneering work in diabetes research and the establishment of TIXiMED.
Kathy Nugent, Ph.D., executive director of the Harbert Institute, highlighted the significance of the FDA clearance. “This is a major milestone in drug development. We are excited about the potential of TIX100 and are proud to support Dr. Shalev’s groundbreaking research,” Nugent said.
The UAB Division of Endocrinology, Diabetes and Metabolism, and the UAB Comprehensive Diabetes Center are integral parts of the UAB Marnix E. Heersink School of Medicine.
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