�Cara Therapeutics, Inc.
announced completion of a Phase I clinical trial for its second-generation,
peripherally playing kappa opioid agonist, CR845, under development for the
treatment of acute and chronic annoyance. The drug candidate was safe and
well-tolerated after intravenous infusion, and resulted in plasm levels of
CR845 expected to be associated with clinical anodyne 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, unmarried escalating
intravenous dose study in 54 healthy male person and distaff volunteers. CR845 was
shown to be safe at all doses investigated, with no reports of serious side
personal effects or contrary central uneasy system natural process. Linear,
dose-proportional increases in systemic exposure to CR845 were ascertained.
Low doses of CR845 resulted in plasma levels at or above the plasma levels
of do drugs expected to be associated with clinical analgesic efficaciousness.
The Company plans to advance its intravenous conceptualization of CR845 into
Phase II trials later in 2008. Based on the demonstrated safety,
tolerability, and bioactivity of this conceptualization in Phase I, Cara will
continue to develop its unwritten 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 length of action relative to Cara's
first base generation of peripheral kappa opioids. Animal studies argue that
CR845 is effective in reducing pain of inflammatory, neuropathic and
nonrational origin. The analgesic and anti-inflammatory personal effects of CR845
lasted for up to 18 hours after a single venus's curse. CR845 was active after
intravenous, hypodermic, or oral administration. Preclinical studies likewise
indicate that CR845 possesses anti-itch properties. Unlike currently
marketed opioids, CR845 did not inhibit intestinal transit (ileus), vitiate
breathing, or elicit signs of addiction in animal models. CR845 and related
compounds ar covered by a late issued U.S. patent.
About Cara Therapeutics
Cara Therapeutics is a in private held biotech company focused on
development novel, superscript therapeutics to treat bother and firing
associated with diverse medical conditions. Cara's current pipeline
includes near-term clinical dose candidates within multiple classes of
peripherally-acting analgesics. Cara also plans to modernize 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 remedial 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 ar 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,
merely are non limited to, the timing, success and cost of Cara's research and
clinical studies and Cara's ability to hold additional financing. These
forward-looking statements represent Cara's sound judgment as of the day of the month of this
release. Cara disclaims any intent or obligation to update these
forward-looking statements.
Cara Therapeutics, Inc.
http://www.caratherapeutics.com
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