CR845 Advances to Phase 2b in Chronic Pain

Enteris BioPharma’s “Feasibility to Licensing” Partner, Cara Therapeutics, Advances Peptelligence®-Engineered CR845 into Phase 2b Clinical Trial in Chronic Pain

Trial to evaluate three tablet strengths of orally-delivered CR845 versus placebo in approximately 330 osteoarthritis patients

Boonton, NJ – January 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 Enteris BioPharma: Enteris Media Relations:
Brian Zietsman, President & CFO
Jason Rando / Amy Wheeler
Tiberend Strategic Advisors, Inc.