Concert Pharmaceuticals Announces FDA Lifts Partial Clinical Hold for CTP-354, A Novel Drug Candidate for Spasticity

Concert Pharmaceuticals, Inc. has announced that FDA has provided notification that the company has completed the necessary preclinical toxicology testing in order to administer repeated doses of CTP-354 in excess of 6 mg per day, lifting its partial clinical hold. As a result, the Concert intends to initiate dosing of 12 mg per day of CTP-354 in the third quarter of this year as part of its ongoing multiple ascending dose Phase I trial.

CTP-354 is a novel, potentially first-in-class, non-sedating, once-daily oral treatment for spasticity. Concert is initially developing CTP-354 for use in patients with spinal cord injury and in patients with multiple sclerosis to address significant unmet medical needs. CTP-354 is a subtype-selective GABAA receptor modulator. GABAA receptors are found in the nervous system and, when activated, reduce the transmission of certain nerve signals. Several classes of widely used drugs target GABAA receptors, including benzodiazepines, but do not have the receptor subtype selectively of CTP-354.