Novel oral Type 1 diabetes drug gains US FDA IND designation

A University of Alabama at Birmingham startup has gained FDA clearance for Investigational New Drug clinical trials for an oral Type 1 diabetes drug, a milestone for diabetes treatment. 

TIXiMED, a startup based at the University of Alabama at Birmingham, has received US FDA approval under an Investigational New Drug route for its novel oral Type 1 diabetes drug TIX100. The clearance will allow TIXiMED to begin human clinical trials. TIX100 was developed based on the work of Anath Shalev, MD, Nancy R and Eugene C Gwaltney Family Endowed Chair in Juvenile Diabetes Research at the university’s Divison of Endocrinology, Diabetes, and Metabolism and director of the institute’s Comprehensive Diabetes Center.  

TIX100 gained IND approval after extensive safety pharmacology and toxicokinetic testing, with extensive development in chemistry, manufacturing, and control to ensure safety during clinical trials. The novel oral drug hopes to reduce the need for daily injections for patients. “Since TIX100 is available orally, it promises to ease the burden of the multiple daily insulin injections or insulin infusions people with Type 1 diabetes depend on,” commented Shalev. “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 Type 1 diabetes.” 

The mechanism of action for TIX100 revolves around TXNIP, a protein involved in oxidative stress and can cause beta cell death and dysfunction when elevated in pancreatic islets. Previous research conducted by Shalev demonstrated the importance of TXNIP in glucose toxicity and diabetic beta cell loss. Inhibiting TXNIP could protect these beta cells, promoting cell health and function. TIX100 effectively inhibits TXNIP, functioning differently from currently approved diabetes drugs. Additionally, non-specific TXNIP inhibition both prevented and reversed overt diabetes. The US FDA clearance will allow TIXiMED to further observe these effects in humans, following on from previous beneficial effects observed in mouse models of diabetes and selected humans with Type 1 diabetes.  

TIXiMED grew out of the Bill L Harbert Institute for Innovation and Entrepreneurship. For her work in diabetes research and developing disease-changing therapies, as well as founding TIXiMED, Shalev was awarded the EntrepreHER Award in 2022. “It is extremely rewarding to see one of our startups reach such an important milestone,” commented T Michael Goodrich, president and executive board chair of TIXiMED and principal at First Avenue Ventures Life Science, Birmingham, Alabama. “I am confident that the continued success of TIXiMED will serve as a great example of what we can achieve when commercialising a university asset, both from a business perspective and in terms of positively impacting the local and global community.” 

Source: 

Type 1 diabetes: UAB startup gains FDA clearance to test novel oral drug [Accessed August 1, 2024] https://www.uab.edu/news/research/item/14275-type-1-diabetes-uab-startup-gains-fda-clearance-to-test-novel-oral-drug