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Cara Therapeutics Initiates Phase Ia/Ib Trial of Tablet Formulation of Oral CR845 for the Treatment of Acute and Chronic Pain

SHELTON, Conn., June 18, 2014 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain by selectively targeting kappa opioid receptors, today announced the dosing of the first subjects in a Phase Ia/Ib clinical trial of an oral tablet formulation of its peripherally-selective kappa opioid agonist, CR845, for the treatment of acute and chronic pain. The company expects to report top-line pharmacokinetic, safety and biomarker data in the fourth quarter of 2014.

The double-blind, randomized, placebo-controlled trial will evaluate the pharmacokinetic and safety profile of single and multiple escalating doses of oral CR845. In addition, the trial will assess activation of kappa opioid receptors through the measurement of an established neuroendocrine biomarker used in a previous Phase 1 trial of a capsule formulation of oral CR845. The study will enroll up to 150 healthy volunteers at a single U.S. site and will assess up to six concentrations of the tablet formulation of oral CR845.

"This Phase I trial of the tablet formulation of oral CR845 represents a key milestone for Cara as we look to expand the clinical development of CR845 beyond the treatment of acute pain in a hospital setting," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "Oral CR845 has the potential to address the significant unmet medical need for a safer, non-abusable alternative to narcotic opioids and NSAIDs for the treatment of moderate-to-severe acute and chronic pain."

About CR845

CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain. 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 pain intensity and opioid-related side effects. In over 400 subjects dosed to date, I.V. CR845 was found to be safe and well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists.

About Tablet Formulation of Oral CR845

The oral tablet formulation of CR845 was synthesized utilizing the peptide formulation technology developed by Enteris Biopharma under a Manufacturing and Clinical Supply Agreement.

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biopharmaceutical 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 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 expected timing for the Company's Phase Ia/Ib clinical trial of the tablet formulation of oral CR845, the design of the trial, including the number of expected subjects in the trial, the timing of the reporting of the topline results of the trial, as well as the potential future regulatory and development milestones for the Company's product candidates. 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, 2013 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 President & CEO Cara Therapeutics, Inc. 203-567-1500 MEDIA CONTACT: Laura Bagby 6 Degrees 872-206-5475 lbagby@6degreesPR.com INVESTOR CONTACT: Jesse Baumgartner Stern Investor Relations 212-362-1200 Jesse@sternir.comSource:Cara Therapeutics