vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for diabetes, today announced the prioritization of its lead program TTP399 as it gears up for Phase 3 pivotal trials.
-Workforce reduction of 65%
-Prioritization of lead program TTP399, a potentially transformative treatment for the reduction of hypoglycemic episodes in type 1 diabetes patients
HIGH POINT, N.C., Dec. 06, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for diabetes, today announced the prioritization of its lead program TTP399 as it gears up for Phase 3 pivotal trials.
TTP399 is a novel, oral, liver-selective glucokinase activator that showed ~40% reduction in hypoglycemic episodes compared to placebo in its Phase 2 study and was granted Breakthrough Therapy Designation by the FDA. In October, the Company announced positive results of its mechanistic study showing no increased risk of ketoacidosis. Additionally, zero hypoglycemic episodes occurred in the TTP399 arm while four occurred on placebo.
Type 1 Diabetes (T1D) is an autoimmune disease with no cure affecting over 1.6 million people today in the United States. Hypoglycemia is the most common acute complication in T1D. Adult-onset T1D has become more common than childhood-onset with more than half of all new cases diagnosed in adult patients. The patient population is expected to grow worldwide, with an estimated projection of 5 million patients in the U.S. by 2050.
Due to its shift in strategic focus, the Company:
- Reduced its workforce by approximately 65%;
- Added several consultants with track records of drug approvals with extensive Regulatory, Clinical, and Biostatistics experience;
- Paused vTv’s development activities on HPP737, a PDE4 inhibitor for treatment of psoriasis, while it evaluates strategic options; and
- Continues to support the development of its partnered programs.
“It is always difficult to restructure but this allows us to focus on TTP399 and our future growth,” said Deepa Prasad, President and Chief Executive Officer of vTv Therapeutics. “Hypoglycemia management is a serious issue impacting the lives of patients and their families. We are very excited to see TTP399’s novel mechanism of action allowing for reduction of hypoglycemic episodes with a well-tolerated safety profile. We continue to engage with the FDA to map out a clear and positive path forward on our Phase 3 pivotal studies with the goal of improving quality of life for patients managing this chronic, burdensome disease.”
About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company committed to improving the lives of diabetes patients by developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by its program for the treatment of type 1 diabetes. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, primary mitochondrial myopathy, and pancreatic cancer.
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