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HIGH POINT, N.C. - vTv Therapeutics Inc. (NASDAQ:VTVT), a biopharmaceutical company in the late stages of drug development, has announced the reinitiation of patient screening for its Phase 3 CATT1 trial. The company, which has seen its stock surge over 54% year-to-date according to InvestingPro data, maintains a strong liquidity position with more cash than debt on its balance sheet. The study is evaluating cadisegliatin, a potential first-in-class oral treatment for type 1 diabetes (T1D), and aims to assess its efficacy and safety over a six-month period.
The trial protocol has recently been amended to shorten the duration from 12 to 6 months, which is expected to accelerate the delivery of topline data. This amendment will not affect key study endpoints, according to the company. The primary endpoint is to compare the incidence of level 2 and level 3 hypoglycemic events between the treatment and placebo groups. With the company’s next earnings report scheduled for May 20, 2025, investors following this development can access comprehensive financial analysis and 8 additional key insights through InvestingPro.
Cadisegliatin has been granted Breakthrough Therapy designation by the FDA, indicating its potential as a significant improvement over existing therapies. The CATT1 study is a randomized, double-blind, placebo-controlled trial that plans to enroll approximately 150 patients across 20-25 sites in the U.S. Participants will be adults diagnosed with T1D and treated with multiple daily insulin injections or continuous subcutaneous insulin infusion.
Continuous glucose monitors (CGM) will be provided to all participants to inform the primary study endpoint. The trial will compare two doses of orally administered cadisegliatin against a placebo. Topline Phase 3 data from the CATT1 study is anticipated in the second half of 2026.
The company’s CEO, Paul Sekhri, expressed enthusiasm for the resumption of the trial and the potential to expedite the process towards a New Drug Application submission. Cadisegliatin, also known as TTP399, is a liver-selective glucokinase activator that, in non-clinical studies, has shown the ability to increase glucokinase activity independently of insulin, which may improve glycemic control through hepatic glucose uptake and glycogen storage.
vTv Therapeutics specializes in developing oral small molecule drug candidates, with a focus on treatments for diabetes and other chronic conditions. The company maintains a healthy financial position with a current ratio of 7.34, indicating strong ability to meet short-term obligations. However, the safety and efficacy of cadisegliatin have not yet been established, and there is no guarantee that it will receive health authority approval or become commercially available for the use being investigated. For deeper insights into vTv’s financial health metrics and valuation analysis, visit InvestingPro.
This news is based on a press release statement and contains forward-looking statements that involve risks and uncertainties. These statements do not guarantee future performance and are subject to change.
In other recent news, vTv Therapeutics has resumed its CATT1 Phase 3 trial for cadisegliatin, following the FDA’s decision to lift a clinical hold. The trial, initially paused due to an unresolved chromatographic signal, will now proceed with a shortened duration from 12 to 6 months. This amendment aims to expedite the process towards a potential New Drug Application submission. H.C. Wainwright has initiated coverage on vTv Therapeutics with a Buy rating and a price target of $36, highlighting the company’s promising position in the Type 1 diabetes market. The lifting of the clinical hold has been well-received, with the company’s stock experiencing a positive response.
Additionally, vTv Therapeutics announced the upcoming resignation of its Executive Vice President and Chief Financial Officer, Steven Tuch, effective March 21, 2025. The company has begun an external search for a successor to Tuch, who will remain until the submission of the Annual Report for the fiscal year ending December 31, 2024. The departure is reported to be amicable, with no disagreements between Tuch and the company. Investors are closely watching these developments as vTv Therapeutics continues to advance its clinical pipeline.
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