Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that it has initiated its Phase 1 clinical program for CTP-692, which is being developed as a novel adjunctive treatment for schizophrenia, a devastating, chronic illness with significant unmet need. CTP-692 is a deuterated form of D-serine, an endogenous co-agonist of the N-methyl-D-aspartate (NMDA) receptor, which has been demonstrated to be important to mood, memory, and cognition. Concerts Phase 1 program will include a crossover pharmacokinetic comparison of CTP-692 to D-serine and single- and multiple-ascending dose studies to assess the safety, tolerability and pharmacokinetic profile of CTP-692 in healthy volunteers. Initial Phase 1 data are expected in the first quarter of 2019.
Significant unmet need still exists to improve upon the existing standard-of-care in schizophrenia and we believe CTP-692 has the potential to act on a key mechanism not addressed today with currently available agents. By enhancing NMDA receptor activity, CTP-692 offers the promise of improved clinical outcomes for patients with schizophrenia, said James Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals. We plan to advance CTP-692 through Phase 1 and then into a single Phase 2 efficacy trial in patients with inadequately controlled symptoms of schizophrenia in 2019.
The Phase 1 program is expected to enroll approximately 80 healthy volunteers. Dosing has been initiated to assess the safety, tolerability, and pharmacokinetics of a single oral dose pharmacokinetic comparison of CTP-692 versus D-serine. Following successful completion of the crossover trial, Concert will assess the safety, tolerability, and pharmacokinetics of single-ascending oral doses of CTP-692 in a double-blind, placebo-controlled trial. The Phase 1 program will also assess multiple doses of CTP-692 dosed orally over several days in a double-blind, placebo-controlled, multiple-ascending dose trial.
The CTP-692 clinical program is supported by Concerts preclinical studies which have shown the potential for CTP-692 to improve upon the safety profile of D-serine. D-serine has been shown to cause nephrotoxicity in published preclinical studies. Concerts preclinical studies have demonstrated that selective deuterium modification resulted in increased exposure of CTP-692 relative to a similar dose of D-serine, and administration of CTP-692 resulted in no changes in serum creatinine and blood urea nitrogen at doses where D-serine caused substantial nephrotoxicity assessed by these kidney markers. These preclinical results were presented by Concert at the American College of Toxicology 2018 Annual Meeting in November 2018.
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