Spasticity Drug to be Tested on Multiple Sclerosis Patients in Early 2015

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Spasticity in MS

Spasticity in MSConcert 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.

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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.”

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