High Point’s vTv Therapeutics Inc. has received the U.S. Food and Drug Administration designation as a Breakthrough Therapy for its TTP399 oral supplement treating type 1 diabetes and psoriasis.

Presently in phase 2 clinical trials, TTP399 works in conjunction with insulin therapy to activate glucokinase, a process catalyzing the body’s breakdown of glucose.

The FDA awards the designation to early stage drug trials that show an optimistic possibility of improving on the therapies presently available. In other words, TTP399 has an apparent advantage over other type 1 diabetes therapies.

With this distinction, the FDA will have a more active role in the TTP399 clinical trial.  vTv has been appointed an FDA sponsor to aid in expediting the trial and providing guidance, including the ability to submit sections of a New Drug Application for review prior to completing the whole report. Additionally, the company will be awarded a direct line of communication with the FDA and a quicker turnaround time once the application is submitted.

This designation was granted due to the Phase 2 SimpliciT-1 study, a multi-center, randomized, double-blind study testing the TTP399 therapy for safety and efficacy, which concluded in 2020. Results showed that along with reducing HbA1c, the measure of long-term glucose control, the frequency and severity of hypoglycemia were decreased by 40%, without increasing the risk of ketosis.

In treating type 1 diabetes, hypoglycemia is the leading cause of illness and potential death.  With low blood sugar being a concern of both doctors and patients, providers are apprehensive in utilizing tight glycemic control. The reduced occurrence of hypoglycemia alongside the TTP399 therapy means vTv is offering a potential solution to an unmet need in the diabetes community.

Presently, nothing can prevent or cure this condition which effects over one million Americans directly, and millions more who engage in the daily care of patients.


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