FDA Halts vTv's Lead Diabetes Drug Due to Chromatographic Signal
The FDA has imposed a clinical hold on vTv Therapeutics' phase 3 trial for cadisegliatin, a drug intended for Type 1 diabetes. This decision comes more than two years after vTv Therapeutics concentrated their efforts on this specific medication. The hold affects the entire cadisegliatin program and stems from an unexpected chromatographic signal detected in a recent human absorption, distribution, metabolism, and excretion (ADME) study. This signal has proven irresolvable using standard mass spectroscopy techniques, as explained by vTv in an update on July 26.
The FDA's hold extends to the phase 3 CATT1 trial for Type 1 diabetes, although no patients have been administered the drug in this trial yet. Despite this, the liver-selective glucokinase activator has shown good tolerance among the 500 patients who have participated in previous trials, where no significant safety concerns were identified.
To lift the hold, the FDA has requested an in vitro study to further characterize the chromatographic signal. The company has not provided specific details about the nature of this signal. Paul Sekhri, CEO of vTv Therapeutics, emphasized that patient safety is the company’s top priority and expressed gratitude for the FDA's thorough investigation. Sekhri indicated that the company is working closely with the agency to resolve the issue and resume the trial as soon as possible. He highlighted the drug's promising efficacy and favorable safety profile in over 500 subjects, expressing optimism about its potential to improve glycemic control and serve as a much-needed oral therapy for Type 1 diabetes.
Originally, a top-line readout from the phase 3 trial was anticipated by the first quarter of 2026. Earlier this year, in February, vTv secured a $51 million private placement aimed at funding the clinical development of cadisegliatin up to this point.
vTv Therapeutics, based in High Point, North Carolina, committed fully to developing the diabetes drug at the end of 2021. This strategic shift included laying off 65% of its workforce and halting work on a psoriasis drug candidate, HPP737. The decision was driven by promising phase 2 study results, which showed a reduction in hypoglycemic episodes by approximately 40%. A mechanistic study also indicated no increased risk of ketoacidosis associated with cadisegliatin.
While the company's pipeline includes other assets, such as a glucagon-like peptide 1 (GLP-1) receptor agonist for Type 2 diabetes known as TTP273, which has completed a phase 2 study, the primary focus in recent financial reports has been on cadisegliatin.
Notably, vTv's efforts in Alzheimer's disease treatment were less successful. Their Alzheimer's drug, azeliragon, failed in a phase 3 trial back in 2018. Nonetheless, the company remains focused on its mission to bring effective treatments for diabetes to market.
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