First Pivotal Trial Will Evaluate I.V. CR845, Dosed Pre- and Postoperatively, in Patients Undergoing Abdominal Surgery
Top-line data expected in 1H'2016
SHELTON, Conn., Sept. 9, 2015 (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 kappa opioid receptors, today announced the initiation of its Phase 3 program for the intravenous (I.V.) formulation of CR845 in postoperative pain with the dosing of the first subjects in an adaptive pivotal trial in patients undergoing a range of abdominal surgeries.
"The initiation of this pivotal trial is an important step toward defining the clinical utility of I.V. CR845 for the treatment of acute postoperative pain," said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. "Following our successful Phase 2 trials with I.V. CR845 in patients undergoing laparoscopic hysterectomy and bunionectomy, we believe that positive results from this general abdominal surgery trial would continue to build a strong foundation for our overall Phase 3 program and ultimate planned submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration."
The CLIN3001 trial is a multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design 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 will enroll up to 600 patients undergoing either hysterectomy, prostatectomy, hemi-colectomy or ventral hernia at 30 clinical sites within the U.S.
Three dose levels of I.V. CR845 (1.0, 2.0 and 5.0 ug/kg I.V.) will be 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 I.V. CR845 treatment on inflammatory biomarkers will also be explored. Top-line data are expected in the first half of 2016.
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 observed 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. In Q3'15, Cara initiated a Phase 2 trial of an oral tablet formulation of CR845, for the treatment of osteoarthritis (OA).
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 activity in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.
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 expected timing of top-line results from the I.V. CR845 adaptive pivotal trial, the results of the trial and the potential clinical utility of I.V. CR845 and the ultimate submission of an NDA for I.V. CR845. 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, 2014, the Quarterly Report on Form 10-Q for the quarter ended June 30, 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.
CONTACT: 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 firstname.lastname@example.org INVESTOR CONTACT: Jesse Baumgartner Stern Investor Relations, Inc. 212-362-1200 Jesse@sternir.com