Concert Pharmaceuticals Announces Results from CTP-692 Phase 2 Trial in Patients with Schizophrenia
CTP-692 Did Not Achieve Primary Endpoint Assessing Positive and Negative Syndrome Scale (PANSS) Total Score at 12 Weeks
“The body of evidence in the field supporting D-serine as an adjunctive treatment for schizophrenia was compelling and led us to advance CTP-692 into a Phase 2 proof of concept study. Unfortunately, we didn’t see the results we hoped for to support continuation of this program. Going forward, we will focus our internal resources on the advancement of CTP-543, which is currently in Phase 3 evaluation for the treatment of alopecia areata, and evaluation of additional pipeline candidates,” stated
The Phase 2 trial was a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of CTP-692. The primary endpoint of the trial was the change in the Positive and Negative Syndrome Scale (PANSS) total score at 12 weeks compared to baseline. A total of 325 patients, already on a stable course of an antipsychotic medication, were randomized to receive 1, 2 or 4-gram doses of CTP-692 or placebo once-daily. CTP-692 did not show a statistically significant improvement over placebo at any of the doses. Additionally, no significant improvements were observed in either the positive or negative symptoms subscales of the PANSS scale at any of the CTP-692 doses evaluated.
In the Phase 2 trial, treatment with CTP-692 was generally well tolerated. The adverse events reported were predominantly mild in severity and equally distributed across the dose groups, including placebo.
Key data slides are available in the Investors section of Concert’s website at: https://ir.concertpharma.com/events-presentations.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including, among others, statements about our expectations regarding the clinical development of CTP-543 and CTP-692, and any other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals and other factors discussed in the “Risk Factors” section of our most recent Quarterly Report on Form 10-Q filed with the
The Yates Network