HIGH POINT –
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 t
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