Cara Therapeutics Announces Removal of FDA Clinical Hold on CLIN3001 Postoperative Pain Trial for I.V. CR845

  • Patient recruitment expected to resume in May
  • Study to evaluate two doses of I.V. CR845 versus placebo

SHELTON, Conn., April 20, 2016 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ: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 received notice from the U.S. Food and Drug Administration (FDA) that it has removed the clinical hold on its adaptive Phase 3 trial of I.V. CR845 for postoperative pain.

The clinical hold was triggered by a protocol-specified stopping criterion, based on elevated serum sodium levels, that was met during the first phase of the study. A subsequent review of unblinded safety data from the first 90 patients dosed was completed by Cara, the study’s Independent Data Monitoring Committee (IDMC), and the FDA.

The results of this safety data review confirmed that increases in serum sodium levels in CR845-treated patients beyond the normal range were dose-dependent and asymptomatic with the lowest frequency of events found in the 1 ug/kg I.V. CR845 group. Based on this safety review and an analysis of efficacy trends, the study will continue as a three-arm trial testing two doses of CR845 (1 ug/kg and 0.5 ug/kg) versus placebo.

"The Cara development team has worked diligently with the FDA to analyze patient data and conclude the Agency’s review process in a timely manner," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "Our unblinded analysis of the initial cohort of patients has identified interim efficacy signals for pain, supplemental opioid use and opioid-related side effects that support our dose selections. We look forward to continuing patient recruitment next month and to providing further updates on our progress later this year.”

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 either 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 more than 440 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.

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 advantages in the treatment of postoperative pain at the dosing levels to be examined in the 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.

CORPORATE CONTACT: Derek Chalmers, Ph.D., D.Sc. President & CEO Cara Therapeutics, Inc. 203-567-1500 MEDIA CONTACT: Annie Starr 6 Degrees 973-415-8838 INVESTOR CONTACT: Jesse Baumgartner Stern Investor Relations, Inc. 212-362-1200

Source:Cara Therapeutics Inc.