Cara Therapeutics Initiates Phase I Study With Oral Formulation Of Novel Peripherally-Acting Kappa Opioid Agonist

First clinical study with oral formulation of company's lead compound, CR845

Shelton, CT /PRNewswire/ - Cara Therapeutics, Inc. today announced the initiation of a first-in-man Phase I clinical trial of an oral formulation of its peptide-based, kappa opioid agonist, CR845, in healthy volunteers. The double-blind, placebo-controlled trial is expected to enroll up to 60 subjects at a single U.S. site and will evaluate the pharmacokinetic, pharmacodynamic and safety profile of single escalating doses of CR845 in enteric-coated capsules. An intravenous formulation of CR845 is currently in Phase II development for the treatment of acute postoperative pain with data expected in 1Q'12.

"Initiation of this Phase I trial represents an important advancement in the clinical potential of CR845 and will provide the basis for developing the drug beyond the treatment of acute pain in a hospital setting," said Frederique Menzaghi, V.P. of R&D at Cara Therapeutics. "There remains a significant unmet need among chronic pain patients for an effective analgesic without the debilitating or dangerous side-effects of currently used narcotic analgesics and NSAIDs. We believe that an oral formulation of CR845 has the potential to provide an effective and safer option for the treatment of chronic pain."

About CR845
CR845 is a highly selective, peptide-based, peripherally-restricted kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain. In a previous randomized, placebo-controlled Phase II study, CR845 demonstrated evidence of analgesic efficacy when administered as a single intravenous dose to women following laparoscopic hysterectomy. In addition to decreases in reported pain levels, patients receiving CR845 required substantially lower amounts of post-operative opioids (narcotics) and showed a significant reduction in the incidence of post-operative nausea and vomiting. A multicenter double-blind, randomized, placebo-controlled 200-patient Phase II trial is ongoing to evaluate the efficacy and safety of intravenous CR845 when administered both pre and post-operatively in women undergoing laparoscopic hysterectomy. Analysis of this trial is expected in 1Q'12. To date, more than 150 human subjects have been exposed to CR845 with no cases of the dysphoria or hallucinations that have been reported with centrally-acting kappa opioids.

About Oral CR845
CR845 oral capsules were formulated using Unigene's peptide formulation technology under a Manufacturing and Clinical Supply Agreement.

About Cara Therapeutics
Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara's current pipeline includes near-term clinical drug candidates identified as mechanistically distinct, peripherally-acting analgesics.

Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of CR845 and about Cara's strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements may include, but are not limited to, the timing, success and cost of Cara's research and clinical studies and Cara's ability to obtain additional financing. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.

SOURCE Cara Therapeutics, Inc.