Concert Pharmaceutical discontinued development of its adjunctive treatment for schizophrenia, CTP-692 (D-serine) after it failed to meet its primary endpoint and other secondary endpoints in a Phase II trial. The trial was a double-blind, randomized, placebo-controlled study to evaluate safety and efficacy of CTP-692. The primary endpoint was change in the Positive and Negative Syndrome Scale (PANSS) total score at 12 weeks compared to baseline.
The 325 participants in the clinical trial were already on a stable course of an antipsychotic medication. They 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. 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. 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.
“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 Roger Tung, Ph.D., president and chief executive officer of Concert Pharmaceuticals.
Concert Pharmaceuticals is a clinical stage biopharmaceutical company that is developing small molecule drugs that it discovered through the application of its DCE Platform® (deuterated chemical entity platform). Selective incorporation of deuterium into known molecules has the potential, on a case-by-case basis, to provide better pharmacokinetic or metabolic properties, thereby enhancing their clinical safety, tolerability or efficacy. Concert’s lead product candidate is in late-stage development for the treatment of alopecia areata, a serious autoimmune dermatological condition. Concert is also assessing a number of earlier-stage pipeline candidates.
This was reported by Concert Pharmaceuticals on February 1, 2021.
Contact information: Justine E. Koenigsberg, Senior Vice President, Corporate Communications and Investor Relations, Concert Pharmaceuticals, Inc., 65 Hayden Avenue, Suite 3000N, Lexington, MA 02421; 781-674-5284; Email: email@example.com; Website: https://www.concertpharma.com/about-concert/about-concert/