Concert Pharmaceuticals, Inc. has begun the second phase 1, single-ascending dose trial with CTP-692, a novel deuterium-modified form of D-serine being developed as an adjunctive treatment for schizophrenia.
CTP-692 is a deuterium-modified analog of endogenous D-serine. It may have the potential to restore NMDA receptor activity in key parts of the brain, thus improving clinical outcomes in patients with schizophrenia.
The initial phase 1 trial, conducted in Australia, evaluated the safety, tolerability, and pharmacokinetics of a single oral dose of CTP-692 versus D-serine. In patients treated with both compounds, CTP-692 increased plasma exposure compared to D-serine. Further, the drug was well tolerated in healthy volunteers and no serious adverse events were reported.
Under an investigational new drug application in the U.S., Concert will evaluate the safety, tolerability, and pharmacokinetics of single-ascending oral doses of CTP-692 in a double-blind, placebo-controlled trial. The trial will also assess the effect of food on the drug’s pharmacokinetics, and will include a study assessing CTP-692 dosed orally over seven days. Topline data is expected by mid-2019.
Source: Seeking Alpha, January 24, 2019