$CARA Initiates Phase 2 Trial of Oral CR845 in Osteoarthritis

SHELTON, Conn., Aug. 17, 2015 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (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 dosing of the first patients in a Phase 2 trial of an oral tablet formulation of its peripherally selective kappa opioid agonist, CR845, for the treatment of osteoarthritis (OA).

“The initiation of this osteoarthritis trial is an important step toward establishing the potential clinical utility of our oral CR845 formulation in the treatment of chronic inflammatory pain,” said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. “CR845’s novel peripheral mechanism of action may ultimately provide a safer, non-abusable alternative to NSAIDs and narcotic opioids, and satisfy a significant unmet need among osteoarthritis patients and potentially general chronic pain patients.”

The Phase 2 trial is a single-blind, randomized, multiple ascending dose trial designed to evaluate the safety, pharmacokinetics (PK) and effectiveness of oral CR845 tablets dosed over a two-week treatment period in OA patients experiencing moderate-to-severe pain, defined as >4 on a 10-point Visual Analog Scale (VAS). The trial will enroll 80 OA patients at multiple sites in the U.S. Four tablet strengths (0.25 mg, 0.5 mg, 1.0 mg and 5 mg) will be administered twice a day. In addition to safety and PK observations, pharmacodynamics endpoints will include change from baseline in joint pain using the Numeric Rating Scale (NRS), change from baseline in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Patient Global Assessment (PGA) of OA. Exploratory measurements of inflammatory biomarkers will be assessed at baseline and post-CR845 treatment.

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 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. Cara expects to initiate its Phase 3 Program of I.V. CR845 for acute pain with a first adaptive pivotal trial in laparoscopic abdominal surgery in 3Q’15.

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 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 Oral CR845’s potential to provide a safer, non-abusable alternative to NSAIDs and narcotic opioids, and satisfy a significant unmet need among osteoarthritis patients and potentially general chronic pain patients, and the expected timing for initiation of the Company’s first adaptive pivotal trial of I.V. CR845 in laparoscopic abdominal surgery. 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.

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