vTv Therapeutics Inc. (NASDAQ: VTVT) has announced encouraging findings of the mechanistic trial of TTP399 on Type 1 diabetes patients.
No ketone levels increase after the insulin withdrawal test
Results showed that during the abrupt insulin withdrawal period in TID patients receiving TTP399, no ketone levels increase relative to placebo, showing no enhanced ketoacidosis risk. In addition, during the treatment week before insulin withdrawal, individuals that received TTP399 had enhanced fasting plasma glucose levels and reduced hypoglycemia occurrences consistent with past clinical studies.
Study investigator and Assistant professor of medicine at the University of California Jermey Pettus said, “This mechanistic study confirms the hypothesis that treatment with TTP399 lowers glucose, results in less hypoglycemia, and does not increase the formation of ketones. These results overcome a major hurdle faced by other potential adjunct therapies, particularly those from the SGLT2 class.”
Jonathan Rosen, JDRF Associate Director of Research, said, “The results from this trial suggest that TTP399 can lower blood glucose without increasing the risk of DKA. This is so important because DKA remains a challenge in people with type 1diabetes and insulin by itself is not enough for most people with T1D to achieve optimal health outcomes—we need safe, effective adjunctive therapies to complement insulin.”
The study met the primary endpoint
The study attained a primary endpoint by showing non-inferiority compared to placebo in the percentage of subjects that reached certain concentration BOHB limits over the acute insulin withdrawal period.
CEO vTv Therapeutics Steve Holcombe said, “It is outstanding to have data supporting TTP399’s favorable profile with respect to ketoacidosis, as regulatory agencies have been highly attuned to DKA in their review of potential treatments for type 1 diabetes. We are making progress towards finalizing the study designs of our Phase 3 pivotal program with the FDA’s continued feedback under Breakthrough Therapy designation and we expect to initiate these clinical studies in early 2022.”