HIGH POINT, N.C. - vTv Therapeutics Inc . (NASDAQ:VTVT), a biopharmaceutical company specializing in the development of oral small molecule drug candidates, announced today that its Phase 3 trial for the diabetes drug cadisegliatin has been put on clinical hold by the U.S. Food and Drug Administration (FDA). The hold was initiated following the identification of an unresolved chromatographic signal in a recent study, which requires further investigation before the trial can proceed.
Cadisegliatin, also known as TTP399, is an investigational oral medication for type 1 diabetes intended to act on the liver to improve glycemic control. It has been administered to over 500 subjects in clinical trials, with treatments lasting up to six months. According to the company, no safety concerns have been raised in these previous studies.
The FDA's decision to halt the CATT1 Phase 3 trial is based on findings from an absorption, distribution, metabolism, and excretion (ADME) study where standard mass spectroscopy techniques could not adequately identify a specific signal. The agency has requested a single in vitro study to characterize this signal before the clinical program can resume.
Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics, stated that patient safety remains the company's top priority and expressed appreciation for the FDA's thoroughness. Sekhri also noted that the company is actively working with the FDA to address the clinical hold and hopes to resume enrollment as soon as possible.
The company has previously described cadisegliatin as demonstrating compelling efficacy and a favorable safety profile. The drug is being considered as a potential first-in-class adjunctive therapy to insulin for the treatment of type 1 diabetes, acting independently from insulin to regulate blood glucose levels.
This news is based on a press release statement from vTv Therapeutics and reflects the company's current expectations regarding the clinical development of cadisegliatin. The company cautions that forward-looking statements are subject to risks and uncertainties and there is no assurance that the clinical trial will resume on the anticipated timeline or achieve the desired outcomes.
In other recent news, vTv Therapeutics has made significant strides in its diabetes research. The biopharmaceutical company's drug, cadisegliatin, has received Breakthrough Therapy designation from the FDA and commenced pivotal trials. This novel treatment, designed to activate glucose pathways in the liver independent of insulin, is being evaluated over a 12-month period in adults with type 1 diabetes.
The company has also announced plans for a Phase 2 trial to evaluate cadisegliatin as an adjunct therapy for type 2 diabetes patients, in collaboration with G42 Healthcare Research Technology Projects LLC and IROS. These developments are part of vTv's ongoing commitment to developing oral small molecule drug candidates, with cadisegliatin leading its clinical pipeline.
In other recent developments, vTv Therapeutics has regained compliance with the Nasdaq Stock Market's minimum market value requirement, ensuring its common stock will continue to be listed on the Nasdaq Capital Market. This achievement has resolved previous uncertainties regarding the company's ability to meet the exchange's listing criteria.
InvestingPro Insights
As vTv Therapeutics Inc. (NASDAQ:VTVT) faces a challenge with the FDA's clinical hold on its Phase 3 diabetes drug trial, investors may be keen to understand the company's financial health and market performance. According to real-time data provided by InvestingPro, vTv Therapeutics holds a market capitalization of 63.38 million USD. Despite experiencing a substantial revenue growth of 5455.56% in the last twelve months as of Q1 2024, the company has reported a negative gross profit margin of -1130.2%, highlighting inefficiencies and potential concerns about its profitability.
InvestingPro Tips for vTv Therapeutics reveal a mixed financial picture. On the positive side, the company holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations, which could provide some financial stability in the face of current clinical trial setbacks. Additionally, the company has seen a strong return over the last month, with a 24.99% price total return, and even more impressively, a 154.67% return over the last six months. These metrics suggest a recent investor confidence that may be attributed to the company's potential in the market.
However, the company is not without its challenges. It suffers from weak gross profit margins and has not been profitable over the last twelve months, which could raise concerns about its long-term financial viability. Furthermore, vTv Therapeutics does not pay a dividend to shareholders, which may detract certain investors seeking regular income from their investments.
For those interested in a deeper dive into vTv Therapeutics' financials and market performance, InvestingPro offers additional insights. There are six more InvestingPro Tips available for vTv Therapeutics, which can be accessed by visiting https://www.investing.com/pro/VTVT. To enhance your investing strategy, use coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.