Cara Therapeutics Initiates Further Phase 1a/1b Trial of Enteris’ Tablet Formulation of Oral CR845 Following Successful Initial Phase 1 Study
BOONTON, N.J., June 20, 2014 — Enteris BioPharma, Inc., an industry leader in innovative oral dosage formulations, today announced that its development partner, Cara Therapeutics (Nasdaq: CARA) has dosed the first subjects in a further Phase 1a/1b clinical trial of a tablet formulation of its peripherally-selective kappa opioid agonist, CR845, for the treatment of acute and chronic pain.
The tablet formulation of oral CR845 was formulated utilizing Enteris’ proprietary oral delivery technology under a Manufacturing and Clinical Supply Agreement. The agreement with Cara Therapeutics is representative of Enteris’ broader “Feasibility-to-Licensing” strategy involving its peptide and small molecule oral drug delivery platform.
Brian Zietsman, President and CFO of Enteris BioPharma, commented, “We are very pleased with the continued progress of oral CR845 as it showcases the potential of Enteris’ proprietary oral delivery technology and the value that we offer to strategic partners. The advancement of oral CR845 adds to the clinical validation of our oral drug delivery platform, 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 partners.”
As reported in the prior Phase 1 study, oral CR845 demonstrated a mean oral bioavailability of 16% across all groups under fasting conditions, with peak and total exposures proportional to each dose. Peripheral kappa opioid receptor activation was seen at all doses tested as measured by a standard biomarker. Additionally, orally administered CR845 appeared to be safe and generally well tolerated across all doses tested.
Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics, remarked, “We continue to be very impressed with the bioavailability and bioactivity exhibited by the oral formulation of CR845, and we look forward to reporting top-line pharmacokinetic, safety and biomarker data from our Phase 1a/1b study in the fourth quarter of 2014. In our estimation, oral CR845 has 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, non-abusable alternatives to narcotic opioids and NSAIDs.”
Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting 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.
Enteris BioPharma, Inc. is a privately held, New Jersey-based biotechnology company offering innovative formulation solutions built around its proprietary drug delivery technologies. Enteris’ proprietary oral delivery technology has demonstrated a track record of clinical success across a range of compounds and therapeutic indications and has also been the subject of numerous feasibility studies and active development programs, several of which are in advanced stages of clinical development. For more information on Enteris BioPharma and its proprietary oral delivery technology, please visit www.EnterisBioPharma.com.
|For Enteris BioPharma:||Media Contacts:|
|Amos J. Sanchez |
|Jason Rando / Claire Sojda |
Tiberend Strategic Advisors, Inc.