Author: Vandana Singh

vTv Therapeutics Inc. (NASDAQ:VTVT) stock is trading lower on Monday. The FDA has placed a clinical hold on the cadisegliatin clinical program, which includes the ongoing CATT1 Phase 3 trial in type 1 diabetes. 

Cadisegliatin is an oral, liver-selective, glucokinase activator. The company says the drug candidate has been well-tolerated in over 500 subjects to date with up to six months of treatment.

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Selectively acting on the liver, cadisegliatin increases the activity of glucokinase independently from insulin to improve glycemic control through hepatic glucose uptake and glycogen storage.

The clinical hold was 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.

The agency requires a single in vitro study to characterize this signal before the cadisegliatin program can resume.

No patient had been dosed in CATT1 at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues.

“We are working diligently with the agency to resolve the clinical hold and resume enrollment as quickly as possible,” said Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics.

Price Action: VTVT stock is down 32.2% at $14.38 at the last check on Monday.

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Intra-Cellular Therapies Inc (NASDAQ:ITCI) unveiled on Tuesday topline results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). 

Topline results from the second Phase 3 study, Study 502, are anticipated late in the second quarter of this year.

Caplyta (lumateperone) is a once-daily pill proven to deliver significant symptom relief from bipolar I and bipolar II depression.

“We believe that these robust efficacy results coupled with its favorable safety and tolerability profile and convenient dosing make CAPLYTA a compelling option as an adjunctive treatment for MDD, if approved,” said Sharon Mates, chairman and CEO of Intra-Cellular Therapies. 

Lumateperone 42 mg, given once daily as adjunctive therapy to antidepressants, met the primary endpoint in Study 501 by demonstrating a statistically significant and clinically meaningful reduction in the MADRS total score compared to placebo at Week 6. 

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Montgomery–Åsberg Depression Rating Scale (MADRS) is a widely used clinician‐rated measure of depressive severity.

In the modified intent-to-treat (mITT) study population, the least squares (LS) mean reduction from baseline for lumateperone 42 mg was 14.7 points versus 9.8 points for placebo, with an effect size of 0.61.

Lumateperone 42 mg also met the key secondary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the CGI-S score (severity of illness), compared to placebo at Week 6, with an effect size of 0.67.

Statistically significant efficacy was seen at the earliest time point tested (Week 1) and maintained throughout the study in the primary and the key secondary endpoints.

In this study, lumateperone 42 mg robustly improved depressive symptoms, as reported by patients.

Lumateperone was generally safe and well-tolerated in this study. 

ITCI Price Action: Intra-Cellular Therapies shares are up 27.60% at $82.64 at publication Tuesday.

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