BOONTON, N.J., Sept. 19,
2016 /PRNewswire/ -- Enteris BioPharma, Inc., a biotechnology
company developing innovative drug products built around its
proprietary delivery technologies, congratulates Cara Therapeutics
(Nasdaq: CARA) on the successful initiation of its Phase 2b
clinical trial of its oral formulation of CR845 for the treatment
of pain associated with osteoarthritis. CR845, an oral tablet
formulation of Cara Therapeutics' peripherally selective kappa
opioid agonist, was engineered using Enteris' proprietary oral
delivery technology, Peptelligence™.
The oral tablet formulation of CR845 was developed in accordance
with a Phase 2 Clinical Manufacturing Services Agreement between
Cara Therapeutics and Enteris whereby Enteris utilized its
Peptelligence™ technology to enable the active ingredient, which
was initially designed for I.V. administration, to be delivered
orally.
Joel Tune, Chief Executive
Officer and Executive Chairman of Enteris BioPharma, commented, "We
congratulate Cara Therapeutics on the initiation of its Phase 2b
clinical trial of its oral tablet formulation of CR845 and look
forward to the top-line data in the first half of 2017. The ongoing
clinical success of oral CR845 illustrates the potential of our
oral drug delivery platform, Peptelligence™, which has been shown
to be safe and well tolerated and has demonstrated clinically
meaningful efficacy and enhanced bioavailability in Phase 2 and
Phase 3 studies conducted by other 'Feasibility-to-Licensing'
partners."
Derek Chalmers, Ph.D., D.Sc.,
President and Chief Executive Officer of Cara Therapeutics,
remarked, "The ability to deliver CR845 orally offers Cara the
potential to address a significant market opportunity in the
treatment of acute and chronic pain for which there continues to be
a very large unmet need for safer, alternatives to narcotic
opioids. We continue to be very impressed with Enteris' proprietary
oral delivery technology and welcome the opportunity to advance
oral CR845 into this Phase 2b clinical trial."
The Phase 2b trial is a randomized, double-blind,
placebo-controlled trial of three tablet strengths of CR845, 1.0
mg, 2.5 mg and 5.0 mg, dosed twice a day (BID) over an eight-week
treatment period in approximately 330 osteoarthritis patients
experiencing moderate-to-severe pain. The primary efficacy endpoint
will be change from baseline at week eight, with respect to the
weekly mean of the daily pain intensity score using a numerical
rating scale (NRS). Secondary endpoints will include: change from
baseline in the Western Ontario
and McMaster Osteoarthritis Index (WOMAC), the Patient Global
Impression of Change (PGIC) and amount of rescue medication
used.
About Cara Therapeutics
Cara Therapeutics is a
clinical-stage biotechnology company focused on developing and
commercializing new chemical entities designed to alleviate pain
and pruritus by selectively targeting peripheral kappa opioid
receptors. Cara is developing a novel and proprietary class of
product candidates that target the body's peripheral nervous system
and have demonstrated efficacy in patients with moderate-to-severe
pain without inducing many of the undesirable side effects
typically associated with currently available pain
therapeutics.
About Enteris BioPharma
Enteris BioPharma, Inc. is a
privately held, New Jersey-based
biotechnology company offering innovative formulation solutions
built around its proprietary drug delivery technologies. The
Company's proprietary oral delivery technology – Peptelligence™ -
has been the subject of numerous feasibility studies and active
development programs, several of which are in late stage clinical
development. Additionally, Enteris BioPharma has built and is
advancing an internal product pipeline of oral tablet
reformulations of drug products that address significant treatment
opportunities for which there is no oral delivery option.
Enteris BioPharma's internal pipeline currently consists of
Ovarest™ (oral leuprolide tablet), a Phase 2a-ready oral peptide
for endometriosis, and Tobrate™ (oral tobramycin tablet) for the
treatment of uncomplicated urinary tract infection (uUTI). The
Tobrate™ Phase 1 clinical program was initiated in July 2016, with data expected in the first
quarter of 2017.
For more information on Enteris BioPharma and its proprietary
oral delivery technology, please visit
www.EnterisBioPharma.com.
For Enteris
BioPharma:
|
Brian Zietsman,
President & CFO
+1.973.453.3527
Enteris Media
Relations:
Jason Rando / Amy
Wheeler
Tiberend Strategic
Advisors, Inc.
+1.212.827.0020
jrando@tiberend.com
awheeler@tiberend.com
|
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SOURCE Enteris BioPharma, Inc.