In July, TIXiMED Inc., a startup founded by UAB professor Anath Shalev, MD, initiated a Phase 1b Multiple Ascending Dose study of TIX100, a novel oral therapy for Type 1 diabetes. TIX100 is designed to inhibit thioredoxin-protein, a protein linked to pancreatic beta-cell loss and diabetes progression.
While existing therapies, including daily insulin injections, help manage blood sugar, no oral treatment currently targets the underlying loss of beta-cell function.
Shalev, co-founded TIXiMED in 2021 through UAB’s Bill L. Harbert Institute for Innovation and Entrepreneurship. The Phase 1b study follows completion of a Phase 1a Single Ascending Dose trial in 2025, in which TIX100 was found to be safe and well tolerated in healthy subjects.
The new double-blind, randomized, placebo-controlled study will evaluate the drug’s safety, tolerability and pharmacokinetics. Researchers will enroll 18 healthy participants across three dose cohorts at a single United States study site. Participants will receive either TIX100 or a placebo twice daily for 28 days, followed by a seven-day follow-up period. Six participants making up the first cohort have been enrolled thus far.