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Formulation Technology

Enteris BioPharma’s Formulation Technology Enables Oral Delivery of Cara Therapeutics’ CR845 Peptide for Acute and Chronic Pain in Phase 1a / 1b Trial

BOONTON, N.J., Dec. 9, 2014 — Enteris BioPharma, Inc., an industry leader in oral peptide delivery, congratulates Cara Therapeutics (Nasdaq: CARA) on the successful completion of the Phase 1a / 1b clinical trial of its peripherally-selective kappa opioid agonist, CR845, for the treatment of acute and chronic pain. Cara’s tablet formulation of CR845 utilizes Enteris’ proprietary oral delivery technology.

The Cara study showed a range of maximum plasma concentrations of CR845 bracketing the concentrations seen in previous Phase 2 studies with IV CR845,  equivalent systemic levels of CR845 in oral and IV administration, dose linearity over a 100 fold range (from 0.1mg to 10mg) and that all doses studied were biologically active, safe and well tolerated.

Brian Zietsman, President and CFO of Enteris BioPharma, commented: “We congratulate Cara Therapeutics on the successful completion of its Phase 1 study of oral CR845. As Cara Therapeutics seeks to expand the clinical development of CR845 beyond the treatment of acute pain in an institutional setting, oral delivery of CR845 will be the key to unlock this opportunity.”

Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics, remarked, “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, alternatives to narcotic opioids.”

About Cara Therapeutics
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.

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. Enteris’ proprietary oral delivery technology has been the subject of numerous feasibility studies and active development programs, several of which are in late stage clinical development. For more information on Enteris BioPharma and its proprietary oral delivery technology, please visit http://www.EnterisBioPharma.com.

For Enteris BioPharma: Media Contacts:
Tim Saxon
973.453.3515                                   tsaxon@enterisbiopharma.com
Jason Rando / Claire Sojda
Tiberend Strategic Advisors, Inc.