The FDA has placed vTv Therapeutics’ phase 3 trial for cadisegliatin on hold more than two years after the biotech stacked its remaining chips on the Type 1 diabetes drug.
The regulator placed the clinical hold across the cadisegliatin program “based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy,” vTv explained in a post-market update July 26.
That hold includes the phase 3 CATT1 trial in Type 1 diabetes, although no patients have yet been dosed in this study, according to the company.
The liver selective glucokinase activator has been well tolerated among the 500 patients who have so far received the drug in other trials, and these past clinical studies “did not reveal any clinically concerning safety issues,” the biotech added in the release.
To resolve the hold, the FDA has asked for an in vitro study to be conducted to characterize the chromatographic signal. The company did not give more details about the exact nature of the signal.
“Patient safety is our top priority, and we appreciate the thoroughness of the FDA to better understand this signal,” vTv CEO Paul Sekhri said in the release.
“We are working diligently with the agency to resolve the clinical hold and resume enrollment as quickly as possible,” Sekhri added. “Cadisegliatin demonstrated compelling efficacy and a favorable safety profile in over 500 subjects dosed to date, and we are highly encouraged at the potential of cadisegliatin to improve glycemic control and be a much-needed oral therapy for type 1 diabetes.”
A top-line readout from the phase 3 trial had been expected by the first quarter of 2026. In February, vTv secured a $51 million private placement that it expected to fund the clinical development of cadisegliatin to this point.
The High Point, North Carolina-based biotech went all-in on the diabetes drug at the end of 2021, laying off 65% of its workforce and halting work on a psoriasis candidate dubbed HPP737. At the time, vTv said its decision was based on reduction in hypoglycemic episodes of around 40% among participants in a phase 2 study of cadisegliatin. A mechanistic study had previously shown no increased risk of ketoacidosis, the company noted.
The company’s pipeline does include other assets, such as a glucagon-like peptide 1 (GLP-1) receptor agonist for Type 2 diabetes called TTP273 that has completed a phase 2 study. However, the sole focus of the company’s most recent earnings report was cadisegliatin.
The biotech’s Alzheimer’s disease prospect azeliragon failed a phase 3 trial back in 2018.