Cara Therapeutics Announces Successful Completion of Phase I Clinical Trial of Novel...

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.

Derek Chalmers, President & CEO of Cara Therapeutics, +1-203-567-1500,
dchalmers@caratherapeutics.com