Cara Therapeutics, Inc.
CARA, a biotechnology company focused on developing and
commercializing new chemical entities designed to selectively target
peripheral kappa opioid receptors, today announced the successful completion
of a Phase 1b trial of an intravenous (I.V.) formulation of CR845 in dialysis
patients. In the repeat dosing of I.V. CR845 over one week was observed to be
safe and well-tolerated across a five-fold dose range, and the trial
established a dosing regimen for the ongoing Phase 2 trial in dialysis
patients with uremic pruritus. The company expects to report top-line data
from this trial in the first half of 2015.
"The completion of this Phase 1b trial and initiation of the Phase 2 study in
uremic pruritus is an important step in establishing the potential clinical
utility of CR845 in this area of significant unmet medical need," said
Frédérique Menzaghi, Ph.D., Vice President of Research and Development at
Cara Therapeutics. "We are particularly encouraged that preliminary data from
this trial indicate that CR845 effectively reduced "worst itching" scores in
those subjects who entered the study with ongoing moderate-to-severe uremic
pruritus. We look forward to reporting top-line data from our Phase 2 trial in
the first half of 2015."
There are currently no approved therapeutics in the United States for uremic
pruritus, an intractable type of itch that is generally resistant to
conventional treatments, and diminishes the quality of life for almost half of
all kidney dialysis patients.
The Phase 1b trial was a double‐blind, randomized, placebo‐controlled trial
designed to evaluate the safety and pharmacokinetics (PK) of I.V. CR845 in 24
hemodialysis patients. I.V. CR845 was administered as a bolus dose (0.5
ug-2.5ug/kg) after each dialysis session up to three times a week (t.i.w.).
Pharmacokinetic analysis indicated that I.V. CR845 exhibited dose linear
increases in Cmax and AUC with an approximate 10-fold increase in AUC across
doses in these dialysis patients compared to normal subjects.
I.V. CR845 was observed to be safe and well tolerated over the one-week dosing
period with no serious adverse events (AEs) reported. The most common AEs were
transient facial tingling and headache. Although uremic pruritus was not an
inclusion criterion for randomization, three subjects entered the trial with
"worst itching" baseline scores in the moderate-to-severe range, >4.0 on a
10.0 point visual analog scale (VAS). All three subjects received t.i.w.
dosing of I.V. CR845 (two subjects at 1ug/kg, one at 2.5ug/kg) and ended the
one-week dosing period with reported "worst itching" scores of 1.0 or less.
"We are very encouraged that our clinical data to date in hemodialysis
patients indicate that CR845 may provide a novel therapeutic approach for
patients suffering the burden of chronic pruritus associated with chronic
kidney disease," said Derek Chalmers, Ph.D., D.Sc., President and Chief
Executive Officer of Cara Therapeutics. "The ability to broaden the potential
clinical utility of CR845 beyond pain into the spectrum of conditions
associated with chronic pruritus is a significant opportunity, and we look
forward to seeing the data from this additional set of patients with uremic
pruritus next year."
The ongoing Phase 2 trial will measure the efficacy of I.V. CR845 compared to
placebo in reducing the intensity of itch in dialysis patients with baseline
"worst itching" scores of 4.0 or greater over a two-week dosing period. The
primary endpoint of the study will be the change from baseline in the average
"worst itching" scores during the second week of treatment, as recorded on a
VAS. Secondary endpoints will focus on quality of life measures associated
with pruritus burden using a series of previously validated self-assessment
scales. The study will enroll a total of 60 dialysis patients at multiple
sites in the U.S.
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