Human clinical trials for this first-in-class therapy are projected to begin in 2H24
TIX100 may become the first oral, non-immunosuppressive treatment for people with type 1 diabetes
By targeting beta cell death and islet cell dysfunction TIX100 addresses an important underlying cause of type 1 and type 2 diabetes
BIRMINGHAM, AL / ACCESSWIRE / July 23, 2024 / TIXiMED, Inc. (https://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, obtained Investigational New Drug (IND) approval from the United States Food and Drug Administration (FDA) for its oral type 1 diabetes drug, the specific TXNIP inhibitor, TIX100. This is a major milestone in the development of the company's novel approach to the treatment of type 1 (T1D) and type 2 diabetes (T2D) and gives TIXiMED the go ahead to start its human clinical trials with TIX100.
Prior to its first use in humans, every new drug has to undergo rigorous safety testing. Indeed, to secure this IND approval, TIX100 underwent extensive toxicology, kinetics and safety pharmacology testing, as well as elaborate chemistry, manufacturing and control (CMC) development to yield extremely pure, medical grade drug product and produce the capsules for the upcoming clinical trial.
The development of TIX100 is based on decades of research that identified the detrimental protein TXNIP as a therapeutic target in human pancreatic islets. TXNIP is elevated in diabetes and leads to beta cell loss, whereas its inhibition protects the body's own insulin producing beta cells and promotes overall islet cell health. This has been demonstrated in different mouse models of diabetes as well as in humans with T1D. TIX100 is a potent and specific TXNIP inhibitor and, as such, functions very differently from any currently approved diabetes drug. Moreover, it is orally available, targets the underlying causes of the disease, and in pre-clinical studies has shown highly promising effects for T1D and T2D.
"Addressing the underlying cause of the disease by suppressing TXNIP with TIX100 holds promise to change the therapeutic landscape of diabetes by preserving the ability of the pancreas to make and secrete insulin," said Dr. Alan Moses, the past Senior VP and Global CMO of Novo Nordisk, a Trustee of the Joslin Diabetes Center, and a member of the TIXiMED Scientific Advisory Board. "Now, with this FDA IND approval, it's exciting to know that we will be able to explore the effects of this novel therapy in humans," Dr. Moses stated.
"We are very pleased to reach this critical milestone in the development of TIX100 and are eager to begin our first-in-human study," said Mr. Mike Goodrich, TIXiMED President and Executive Board Chair. "Additionally, having secured this FDA approval makes this investment opportunity even more compelling and positions the company well for success going forward," Mr. Goodrich added.
About TIXiMED Inc.
TIXiMED is a clinical stage 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 non-alcoholic fatty liver disease. Visit www.tiximed.com for more information.
For Additional Information, please contact:
Emma Bolden
info@tiximed.com
+1.205.578.1005
SOURCE: TIXiMED Inc.
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