The US Food and Drug Administration (FDA) has removed the clinical hold on vTv Therapeutics’ cadisegliatin clinical programme, including the Phase III CATT1 trial for type 1 diabetes (T1D).
This development allows the company to resume the trial, which is now expected to have a reduced duration from 12 to six months. By doing this, vTv aims to rapidly receive topline data from the trial.
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The liver-selective glucokinase activator was found to be well tolerated in more than 500 subjects for up to six months of treatment.
vTv plans to file a protocol amendment to shorten the CATT1 trial duration, aiming to accelerate larger pivotal trials for future new drug application (NDA) rollouts.
The trial’s original primary endpoint, assessing level two and three hypoglycaemia rates at six months, will remain unchanged.
The amendment planned by the company excludes the additional six-month duration to gather the safety data.
vTv Therapeutics CEO, president and chairman Paul Sekhri said: “We are pleased that the FDA has lifted the clinical hold on our cadisegliatin programme and are eager to resume our Phase III trial.
“Cadisegliatin has the potential to be the first oral adjunctive therapy to insulin for T1D, and we look forward to further evaluating the effects of cadisegliatin on glycaemic control and incidence of hypoglycaemia over insulin alone after reinitiating the CATT1 Phase III trial.”
In July last year, the company faced a setback when a clinical hold was placed by the agency on the CATT1 trial due to an unresolved chromatographic signal detected in a human absorption, distribution, metabolism, and excretion (ADME) study of the therapy. The signals were not able to be resolved by standard mass spectroscopy.
However, the company noted that no subject had been dosed at that time, and previous trials did not indicate any significant safety concerns.
The clinical hold was lifted after the company submitted a comprehensive response letter clarifying that the chromatographic signal was an ‘experimental artifact’.
Cadisegliatin is being examined as a potential oral adjunctive treatment to insulin for T1D. Nonclinical studies suggest that the therapy may improve glycaemic control via the uptake of hepatic glucose and storage of glycogen without depending on insulin.
