Benzinga | Feb 1, 2021 07:02AM EST

Concert Pharmaceuticals Announces CTP-692 Phase 2 Trial Did Not Achieve Primary Endpoint Assessing Positive and Negative Syndrome Scale Total Score At 12 Weeks

CTP-692 Did Not Achieve Primary Endpoint Assessing Positive and Negative Syndrome Scale (PANSS) Total Score at 12 Weeks

Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) today announced that its Phase 2 clinical trial to evaluate CTP-692 as an adjunctive treatment in patients with schizophrenia did not meet the primary endpoint or other secondary endpoints. CTP-692 is a deuterated form of D-serine, an endogenous amino acid that is a co-agonist of the NMDA receptor.

"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. "We believe that we conducted a well-designed, well-controlled study and extend our gratitude to the patients, caregivers and investigators for their participation in the CTP-692 Phase 2 study. It's our hope that these learnings will support future research to address the important need to improve the symptom domains of schizophrenia."

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.