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Cara Therapeutics Resumes Patient Recruitment for Adaptive Phase 3 Trial of I.V. CR845 in Postoperative Pain

Trial to evaluate two doses of I.V. CR845 versus placebo following various types of abdominal surgery

Cara Therapeutics, Inc. (CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors, today announced that it has resumed patient recruitment after the U.S. Food and Drug Administration (FDA) removed a clinical hold on its CLIN3001 adaptive Phase 3 trial of I.V. CR845 for postoperative pain.

“We are very pleased that we were able to complete our patient safety data review with the FDA and quickly resume recruitment for the CLIN3001 trial,” said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. “Based on this safety review and an analysis of dose-related efficacy signals, this pivotal study will continue as a three-arm trial comparing two doses of CR845 (1.0 and 0.5 ug/kg) to placebo. We look forward to providing updates on our progress later this year, as we work to provide patients with a differentiated treatment option that is not limited by the side effects and abuse potential of currently available opioid pain therapeutics.”

About the CLIN3001 Trial

The CLIN3001 study is a multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design Phase 3 trial with repeated doses of I.V. CR845 or placebo administered both prior to and following abdominal surgery in male and female patients. The trial is enrolling up to 450 patients undergoing hysterectomy, prostatectomy, hemi-colectomy or ventral hernia repair at approximately 30 clinical sites within the U.S. Two dose levels of I.V. CR845 (1.0 and 0.5 ug/kg, I.V.) are being compared to placebo. The primary efficacy measure is the Change in Pain Intensity over the 24-hour postoperative period (AUC-24) using the patient-reported Numeric Rating Scale (NRS) score collected at pre-specified time points through 24 hours. Postoperative nausea and vomiting (PONV) will be evaluated as a secondary efficacy measure. The impact of CR845 treatment on inflammatory biomarkers is also being explored.

About CR845

CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and pruritus. In multiple randomized, double-blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in both pain intensity and opioid-related side effects. In a human abuse liability trial, I.V. CR845 demonstrated statistically significant reductions in “drug liking,” “feeling high,” “overall liking,” and “take drug again” scores in comparison to I.V. pentazocine, a Schedule IV analgesic. In more than 635 subjects dosed to date, I.V. CR845 was found to be well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists.

An oral formulation of CR845 has also been evaluated in a Phase 2a study in osteoarthritis patients and was shown to be well tolerated with twice a day dosing for two weeks, with evidence of decreasing pain scores during that time period.

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated initial efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.

Forward-looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the resumption of recruitment and dosing in the CLIN3001 clinical trial and the potential for I.V. CR845 to provide efficacy in the treatment of postoperative pain at the dosing levels to be employed in the resumed clinical trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Annie Starr
6 Degrees

Jesse Baumgartner
Stern Investor Relations, Inc.

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