- No drug-associated adverse effects were reported
- Oral drug was well tolerated and no clinically significant findings or safety concerns were noted
- Escalation to the second dose cohort of this single ascending dose study continues per protocol
BIRMINGHAM, Ala.--(BUSINESS WIRE)--TIXiMED Inc. (www.tiximed.com), a clinical-stage pharmaceutical company based on the breakthrough discovery that TXNIP plays an important role in the development and progression of diabetes, today announced successful dosing of the first dose cohort in the Phase 1 Single Ascending Dose (SAD) trial of TIX100, its investigational novel oral therapy targeting beta cell health and islet cell function. Additionally, based on the safety review meeting, it was recommended that the randomized, placebo-controlled quadruple-blind clinical trial continue with no modifications and the next cohort escalate to the pre-specified dose level.
“We are pleased to achieve this significant milestone in the development of TIX100 with this first-in-human trial,” said Dr. Anath Shalev, TIXiMED Founder and Chief Scientific Officer. “We look forward to evaluating the findings of the next, higher dose cohorts in the coming months and to a successful completion of the SAD trial later this year,” Dr. Shalev added.
“We have seen increasing recognition of the promise of TIX100 to one day improve the lives of people with type 1 diabetes,” said TIXiMED President and Board Chair Mike Goodrich. “This first-in-human trial is the cornerstone of the clinical work we’ve planned to advance this novel therapy. We are very thankful to our investors and partners, including The Helmsley Charitable Trust, who have made our progress possible,” Mr. Goodrich concluded.
About TIXiMED Inc.
TIXiMED is a clinical stage pharmaceutical company dedicated to developing and commercializing a first-of-its kind oral therapy for type 1 diabetes based on TXNIP inhibition. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small molecule TXNIP inhibitor, and its derivatives, that has been shown to protect against models of type 1 and type 2 diabetes as well as metabolic dysfunction–associated steatotic liver disease. Visit www.tiximed.com for more information.
Contacts
Emma Bolden
info@tiximed.com
+1.205.578.1005
