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Cara Therapeutics Announces Successful Completion of Phase I Clinical Trial of Novel Analgesic, CR845

SHELTON, Conn., Aug. 5 /PRNewswire/-- Cara Therapeutics, Inc. today announced completion of a Phase I clinical trial for its second-generation, peripherally acting kappa opioid agonist, CR845, under development for the treatment of acute and chronic pain. The drug candidate was safe and well-tolerated after intravenous infusion, and resulted in plasma levels of CR845 expected to be associated with clinical analgesic activity. In addition, CR845 infusion triggered a quantitative endocrine biomarker of peripheral kappa opioid receptor activation at the lowest dose tested.

The Phase Ia single-center clinical trial evaluated the safety, tolerability, pharmacokinetic profile, and pharmacological activity of CR845 in a double-blind, randomized, placebo-controlled, single escalating intravenous dose study in 54 healthy male and female volunteers. CR845 was shown to be safe at all doses investigated, with no reports of serious side effects or adverse central nervous system activity. Linear, dose-proportional increases in systemic exposure to CR845 were observed. Low doses of CR845 resulted in plasma levels at or above the plasma levels of drug expected to be associated with clinical analgesic efficacy.

The Company plans to advance its intravenous formulation of CR845 into Phase II trials later in 2008. Based on the demonstrated safety, tolerability, and bioactivity of this formulation in Phase I, Cara will continue to develop its oral formulation of CR845 for advancement into Phase I.

About CR845

CR845 was designed to be highly selective for the peripheral kappa opioid receptor, with a prolonged duration of action relative to Cara's first generation of peripheral kappa opioids. Animal studies indicate that CR845 is effective in reducing pain of inflammatory, neuropathic and visceral origin. The analgesic and anti-inflammatory effects of CR845 lasted for up to 18 hours after a single dose. CR845 was active after intravenous, subcutaneous, or oral administration. Preclinical studies also indicate that CR845 possesses anti-itch properties. Unlike currently marketed opioids, CR845 did not inhibit intestinal transit (ileus), impair breathing, or elicit signs of addiction in animal models. CR845 and related compounds are covered by a recently issued U.S. patent.

About Cara Therapeutics

Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara's current pipeline includes near-term clinical drug candidates within multiple classes of peripherally-acting analgesics. Cara also plans to develop entirely novel classes of analgesics that emerge from its proprietary GPCR DimerScreen(TM) technology.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of CR845 and about Cara's strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Cara's research and clinical studies and Cara's ability to obtain additional financing. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.

SOURCE Cara Therapeutics, Inc.
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