Cerevel surges on positive data for CVL-231 in schizophrenia trial, start of public offering

Shares in Cerevel Therapeutics jumped as much as 136% Tuesday after the company reported "clinically meaningful and statistically significant" Phase Ib study results for CVL-231, a muscarinic M4-selective positive allosteric modulator under development for adults with schizophrenia. The experimental treatment was also generally well-tolerated, and discontinuation rates were similar between CVL-231 and placebo in the six weeks of dosing, at 22% each.

Part B of the trial included 81 patients with baseline Positive and Negative Syndrome Scale (PANSS) total scores of at least 80, and who were experiencing acute exacerbation of psychosis. Participants were randomised to receive CVL-231, at a dose of 20 mg twice daily or 30 mg once daily, or placebo for a total of six weeks. The measures used for evaluation included change from baseline in PANSS total score, as well as on the negative, positive and general psychopathology subscales.

Top-line results showed that the 30 mg once-daily dose led to a significant mean reduction from baseline of 19.5 points in the PANSS total score, and a mean decrease of 12.7 points when compared to placebo. Results in the 20 mg twice-daily cohort were also significant, with a reduction of 17.9 points from baseline in PANSS total score, and a decline of 11.1 points versus the placebo group. Cerevel noted that the trial was 59% powered to detect a seven-point difference from placebo on the PANSS total score. The company said the data were further supported by "clinically meaningful reductions" in the PANSS positive and negative subscales as well.