SHELTON, Conn., Jan. 12 /PRNewswire/ -- Cara Therapeutics, Inc. today announced that it is initiating a Phase II clinical trial of its long-acting peripheral kappa opioid agonist, CR845. The Phase II multi-center, double-blind, placebo-controlled trial will be conducted in the United States and will evaluate the analgesic efficacy and safety of intravenous CR845 during the post-operative period in women following laparoscopic-assisted hysterectomy. The trial is expected to enroll 120 patients, who will be randomly selected for treatment with one of two doses of CR845 or placebo. Results from the study are expected in the second half of 2009.
The Company also expects to initiate a Phase I study of an oral formulation of CR845 later in 2009.
A previous Phase Ia single-center clinical trial of intravenous CR845 evaluated the safety, tolerability, pharmacokinetic profile, and pharmacological activity of the compound 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 stimulated physiological biomarkers of peripheral kappa opioid receptor activity, and also produced plasma levels of drug associated with analgesic efficacy in multiple preclinical studies.
In preclinical studies, CR845 was highly selective for the peripheral kappa opioid receptor. Animal studies indicate that CR845 is effective in treating pain of inflammatory, neuropathic and visceral origin and exhibited analgesic efficacy for up to 18 hours after a single dose. Analgesic activity was seen after intravenous, subcutaneous, or oral administration. Oral bioavailability was confirmed in multiple species. In contrast to currently marketed opioids, CR845 did not produce inhibition of intestinal transit (ileus) or elicit signs of abuse or addiction liability in animal models. Preclinical studies also indicate that CR845 possesses anti-itch activity.
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 identified as mechanistically distinct, peripherally-acting analgesics.
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 may 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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