Concert Pharmaceuticals Initiates Phase 1 Multiple-Ascending Dose Trial of CTP-692

Concert Pharmaceuticals (NASDAQ:CNCE) has started an additional trial in the Phase 1 program evaluating CTP-692, a deuterium-modified form of D-serine as an adjunctive treatment for schizophrenia.

As quoted in the press release:

The Phase 1 multiple-ascending dose trial will evaluate the safety, tolerability, and pharmacokinetic profile of CTP-692 in healthy volunteers. Topline data from both the single-and multiple-ascending CTP-692 Phase 1 trials are expected in the second quarter of 2019.

“The Phase 1 studies evaluating the dosing and safety of CTP-692 are expected to support advancement into an efficacy study in patients with schizophrenia later this year. D-serine is an important endogenous co-agonist of the NMDA receptor in humans which has been shown to be present at lower levels in the blood and cerebrospinal fluid in individuals with schizophrenia. We are pleased with CTP-692’s pharmacokinetic and safety profile to date and believe that it has the potential to offer a safe and effective agent to enhance NMDA function, providing a new approach to treating symptoms of schizophrenia,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “CTP-692 represents the fastest moving program in our pipeline to date, demonstrating our team’s ability to rapidly identify and pursue compelling new therapeutic opportunities based on Concert’s deuterium chemistry platform.”

The Phase 1 program is designed to assess CTP-692’s safety, tolerability and pharmacokinetics in approximately 80 healthy volunteers. The Phase 1 program includes three studies: a crossover comparison of CTP-692 versus D-serine, a single-ascending dose study that also assessed the effect of food on the pharmacokinetics of CTP-692, and the multiple-ascending dose trial announced today. This trial is a double-blind, placebo-controlled, multiple-ascending dose trial assessing CTP-692 dosed orally over seven days. In individuals treated in the crossover study with both CTP-692 and D-serine, CTP-692 was found to have increased plasma exposure compared to D-serine. In addition, CTP-692 was found to be well tolerated in healthy volunteers and no serious adverse events were reported.

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