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HIGH POINT, N.C. - vTv Therapeutics Inc. (Nasdaq:VTVT), a $105 million market cap biotechnology company currently trading at $14.30, announced Thursday that the first participant has been randomized in its CATT1 Phase 3 trial testing cadisegliatin as an adjunctive treatment to insulin for adults with type 1 diabetes. According to InvestingPro data, analysts have set price targets between $35-36 for the stock, suggesting significant upside potential if the trial succeeds.
Cadisegliatin is a potential first-in-class, oral, liver-selective glucokinase activator that has received Breakthrough Therapy designation from the U.S. Food and Drug Administration. The compound has been well-tolerated in over 500 subjects with treatment durations up to six months.
The Phase 3 CATT1 trial will be conducted at up to 25 U.S. sites and is expected to enroll approximately 150 participants. The randomized, double-blind, placebo-controlled study will evaluate two different dose regimens of cadisegliatin (800 mg once or twice daily) versus placebo over six months in adults with type 1 diabetes who are currently using insulin therapy.
"Randomizing the first participant in CATT1 represents another key milestone for vTv’s development of cadisegliatin as a potential therapy to improve glycemic control for the nearly 1.6 million Americans living with T1D," said Dr. Thomas Strack, Chief Medical Officer of vTv Therapeutics. InvestingPro analysis shows the company maintains a strong liquidity position with a current ratio of 7.39, providing adequate resources for trial completion. Two analysts have recently revised their earnings expectations upward for the upcoming period.
The primary endpoint of the study will measure the incidence of level 2 and 3 hypoglycemic events in participants receiving the treatment compared to those on placebo. Secondary endpoints include reduction in hemoglobin A1C, time in target range of glycemic control, and incidence of diabetic ketoacidosis.
According to the company’s press release statement, topline results from the trial are expected in the second half of 2026.
Currently, there is no FDA-approved oral adjunct therapy to insulin for treating type 1 diabetes, despite advances in medical devices used to manage blood glucose levels. While the company holds more cash than debt on its balance sheet, InvestingPro subscribers can access 8 additional key insights about vTv’s financial health and market position to make more informed investment decisions.
In other recent news, vTv Therapeutics has made significant strides in its drug development initiatives. The company has reinitiated patient screening for its Phase 3 CATT1 trial, which focuses on cadisegliatin as a potential first-in-class oral treatment for type 1 diabetes. The trial’s protocol has been amended to shorten its duration from 12 to 6 months, aiming to expedite the delivery of topline data without affecting key study endpoints. This development is part of vTv Therapeutics’ broader strategy to accelerate its drug pipeline. Additionally, the company has appointed Michael Tung, M.D., MBA, as Executive Vice President and Chief Financial Officer. Dr. Tung brings over two decades of experience in finance and corporate strategy within the biopharmaceutical sector. His appointment is seen as a strategic move to bolster the company’s financial leadership as it progresses with its clinical trials. These developments underscore vTv Therapeutics’ commitment to advancing its therapeutic candidates efficiently.
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