Concert Pharmaceuticals, Inc. will announce their latest results from the Phase 1 data of CTP-354, a drug developed to treat spasticity — a chronic condition associated with patients with brain disorders, including Multiple Sclerosis — at the next American Neurological Association’s Annual Meeting in Baltimore, Maryland.
The Phase 1 randomized, double-blind, placebo-controlled trial, was performed in 30 healthy individuals with the primary endpoint to evaluate the drug’s safety and tolerability with three different dosages — 2 mg, 6 mg. and 12 mg — to be administered over the course of 10 days.
The results to be presented will show CTP-354 was well tolerated, with a plasma half-life of 20 hours observed in all tested doses and without interference in both fasted and fed states.
According to these latest results and together with results obtained from a previous phase trial (that determined support for CTP-354 once a day dose and a sustained occupancy of GABBA receptors in the brain), Concert Pharmaceuticals announced a Phase 2 trial will be initiated by the end of this year. The Phase 2 trial will focus on the effects of CTP-354 in spasticity associated with spinal cord injury and spasticity associated with multiple sclerosis.
Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals commented, “We are very pleased to have completed our clinical evaluation of CTP-354 in this Phase 1 trial,” adding the company remains on track to launch the Phase 2 testing later in the year, which initially will target spasticity in patients with spinal cord injury. This study will be followed by a Phase 2 trial in multiple sclerosis patients, which is slated to begin in early 2015.
“CTP-354 was designed to avoid dose-limiting sedation and ataxia, which currently limit the broader use of other GABAA receptor modulators such as benzodiazepines,” noted Tung. “This trial provides evidence that CTP-354 can achieve high plasma levels without causing those side effects. In addition to being generally well tolerated in our Phase 1 clinical trials, CTP-354 also demonstrated highly favorable pharmacokinetics with low variability, dose-proportional exposure, a long half-life in the body and high levels of GABAA receptor occupancy. Taken together, we believe these results support once-daily dosing, which would provide a substantial improvement over the three-times-daily dosing required by current standard-of-care oral spasticity medicines.”