HIGH POINT, N.C. - vTv Therapeutics Inc . (NASDAQ:VTVT), a biopharmaceutical company, announced today that its diabetes treatment cadisegliatin has begun pivotal trials. This drug, aimed at treating type 1 diabetes (T1D), has been granted Breakthrough Therapy designation by the FDA. The designation is based on cadisegliatin's potential as a first-in-class oral liver selective glucokinase activator.
The CATT1 pivotal trial will assess the efficacy and safety of cadisegliatin over 12 months in adults with T1D. The study is randomized, double-blind, and placebo-controlled, with plans to enroll around 150 patients across up to 20 U.S. sites. Participants will be evaluated for the incidence of severe hypoglycemic events, a critical measure for diabetes treatments.
Cadisegliatin's mechanism is designed to activate glucose pathways in the liver independent of insulin, potentially easing the burden of maintaining glycemic control. According to vTv Therapeutics, the drug has already been dosed in over 500 subjects, including 300 patients with diabetes.
Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics, stated that screening the first patient in the CATT1 trial is a significant step towards providing a new treatment option for the nearly 8 million people worldwide with T1D. Dr. Thomas Strack, Chief Medical Officer, highlighted the need for such a treatment by pointing out that 85% of T1D patients experience frequent hypoglycemic episodes, which cadisegliatin aims to mitigate.
Additionally, cadisegliatin will be evaluated as an adjunct therapy to insulin for type 2 diabetes (T2D) patients in a planned Phase 2 trial in the Middle East, in collaboration with G42 Healthcare Research Technology Projects LLC and IROS.
The company's focus remains on developing oral small molecule drug candidates, with cadisegliatin leading its clinical pipeline. While the press release contained forward-looking statements regarding the drug's potential and the anticipated outcomes of the trials, these statements are subject to various risks and uncertainties.
In other recent news, vTv Therapeutics, a clinical-stage biopharmaceutical company, has regained compliance with the Nasdaq Stock Market's minimum market value requirement. The Nasdaq notified the company that its market value of listed securities (MVLS) had reached the necessary threshold to meet the Nasdaq Listing Rule 5550(b)(2), which mandates a minimum MVLS of $35 million. This development means that vTv Therapeutics' common stock will continue to be listed on the Nasdaq Capital Market.
The company's achievement in boosting the MVLS to the required level is a significant stride. Compliance with these rules is essential for maintaining investor confidence and access to capital markets. This notification from Nasdaq has resolved the previous uncertainty regarding vTv Therapeutics' ability to satisfy the exchange's listing criteria.
InvestingPro Insights
As vTv Therapeutics Inc. (NASDAQ:VTVT) embarks on pivotal trials for its promising diabetes drug cadisegliatin, investors are closely monitoring the biopharmaceutical company's financial health and stock performance. Recent data from InvestingPro presents a mixed picture, reflecting both the company's potential and the challenges it faces.
InvestingPro Data indicates a market capitalization of $56.68 million USD, signifying a relatively small player in the biopharmaceutical industry. The company's P/E Ratio stands at -2.37, with an adjusted P/E Ratio for the last twelve months as of Q1 2024 at -3.08, underscoring the company's current lack of profitability. Nonetheless, the Revenue Growth over the same period is reported at an impressive 5455.56%, although it's important to note that this comes from a very low base, given the Revenue figure is just $1 million USD.
An InvestingPro Tip highlights that vTv Therapeutics holds more cash than debt on its balance sheet, which is a positive sign of financial stability, especially important for a company in the capital-intensive biopharmaceutical sector. This could provide the company with a buffer as it continues to invest in the development of cadisegliatin and other drug candidates. Another tip points out that the company's stock has experienced a large price uptick over the last six months, with a 109.45% return, potentially indicating investor confidence in the company's long-term prospects despite recent short-term volatility.
Investors interested in a deeper analysis of vTv Therapeutics can explore additional InvestingPro Tips to gain further insights into the company's financial metrics and stock performance. There are currently 7 more tips available on InvestingPro, which can be accessed at https://www.investing.com/pro/VTVT. For those looking to subscribe, remember to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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