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Concert Pharmaceuticals Initiates Phase 1 Clinical Trial of CTP-354, a Potential Treatment for Spasticity and Pain

June 10, 2013

LEXINGTON, MA – Concert Pharmaceuticals today announced that it has initiated a Phase 1 clinical trial with CTP-354.  CTP-354 is a novel GABA(A) receptor subtype-selective modulator that has demonstrated no sedation at therapeutic doses in preclinical models in contrast to existing GABA(A)receptor non-selective agonists, such as benzodiazepines.  Concert is developing CTP-354 for the potential treatment of spasticity and chronic pain.  The Phase 1 single ascending dose study will evaluate the safety, tolerability and pharmacokinetics of CTP-354 in healthy volunteers.  The company also intends to conduct a Positron Emission Tomography (PET) study to assess brain receptor occupancy of CTP-354 in healthy volunteers.  Concert expects to report top-line results of the Phase 1 single ascending dose study by year-end.

“There is a significant unmet need for effective and better tolerated agents in the treatment of both spasticity and chronic pain, particularly treatments that would reduce or avoid the adverse events of sedation and ataxia that are commonly associated with existing treatments,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals.  “Based on CTP-354’s preclinical profile, we believe it has the potential to offer patients effective treatment for these chronic conditions with an improved therapeutic profile.  We look forward to assessing CTP-354 in our clinical program.”

The Phase 1 study is a randomized, double-blind, placebo controlled study to assess single ascending doses of CTP-354 in healthy adult volunteers in the United States.  The program advanced into Phase 1 clinical testing following successful preclinical studies with CTP-354 (previously referred to as C-21191).  CTP-354 was developed based on an earlier generation of investigational GABA(A)receptor modulators that demonstrated promising receptor subtype selectivity, but lacked a favorable pharmacokinetic profile.  Concert’s selective incorporation of deuterium in CTP-354 significantly improved pharmacokinetic properties in preclinical models while maintaining the desirable pharmacological activity seen with the earlier generation modulators.

About CTP-354

CTP-354 is a novel, orally available, GABA(A) receptor subtype-selective modulator that represents a potential new therapeutic modality for the treatment of spasticity and chronic pain.  CTP-354, with its uniquely favorable specificity at the GABA(A) receptor, was developed using Concert's DCE Platform® (deuterated chemical entity platform) as an agent with optimized metabolic stability and duration of effect.

Benzodiazepines, a clinically-validated class of GABA(A)receptor non-subtype-selective agonists, have beneficial actions including spasmolytic, analgesic and anxiolytic activity.  Their clinical use is often limited by sedation and ataxia, effects that are believed to be due to agonist activity at the GABA(A) alpha1-receptor subtype.  CTP-354 has been shown to lack agonist activity at the GABA(A) alpha1–receptor subtype, but has potent partial agonist activity at other key GABA(A) receptor subtypes. In preclinical models CTP-354 maintained the desirable pharmacology of benzodiazepines with no apparent sedation at therapeutic doses.  Additionally, CTP-354 demonstrated efficacy in a preclinical model of neuropathic pain.

Concert collaborated with Fast Forward, LLC, a subsidiary of the National Multiple Sclerosis Society, which provided funding to support the preclinical advancement of CTP-354.

The U.S. Patent and Trademark Office has issued U.S. Patent No. 8,003,646 claiming CTP-354 and other deuterium-containing GABA(A) modulators as novel compositions of matter.  A corresponding patent has also issued in Japan as Japanese Patent No. 5183808.

About Concert

Concert Pharmaceuticals is a clinical stage biotechnology company with a broad development pipeline targeting renal disease, CNS disorders, inflammation and hematologic disorders.  Concert  is focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel and differentiated small molecule drugs and leveraging decades of pharmaceutical and clinical experience to reduce the time, risk and expense needed to create important new medicines. For more information on Concert Pharmaceuticals, please visit www.concertpharma.com.

Concert Pharmaceuticals Inc., the CoNCERT Pharmaceuticals Inc. logo and DCE Platform are registered trademarks of Concert Pharmaceuticals, Inc.

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