Trial to evaluate pharmacokinetics and safety of three tablet strengths of Oral CR845

BOONTON, NJ, USA I October 31, 2017 I 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 1 clinical trial of its oral formulation of CR845 in patients with stage III-V chronic kidney disease (CKD) who are not on dialysis. An oral tablet formulation of Cara Therapeutics’ peripherally selective kappa opioid agonist CR845, was engineered using Enteris’ proprietary oral delivery technology, Peptelligence™.

The oral tablet formulation of CR845 was developed in accordance with a Manufacturing and Clinical Supply Agreement between Cara Therapeutics and Enteris whereby Enteris utilized its Peptelligence™ technology to enable the active ingredient, which was initially formulated for I.V. administration, to be delivered orally. Under the terms of the “Feasibility-to-Licensing” program, Enteris will continue to manufacture the oral tablet formulation of CR845 for current and potential future studies through Phase 2 that Cara Therapeutics elects to pursue. Cara Therapeutics has the option to negotiate a license to the Peptelligence™ technology for Oral CR845 from Enteris at any time.

“We congratulate Cara Therapeutics on the initiation of its Phase 1 clinical trial of Oral CR845 in non-hemodialysis chronic kidney disease and the potential for Cara to utilize data from this study to inform dose selection and design of a planned placebo-controlled Phase 2 trial in patients with chronic kidney disease-associated pruritus (CKD-aP),” said Joel Tune, chief executive officer and executive chairman of Enteris BioPharma. “Extending Oral CR845 into the treatment of pruritus, in addition to chronic pain, further illustrates the potential of our oral drug delivery platform, Peptelligence™. Peptelligence has been shown to be safe and well tolerated oral delivery system and has demonstrated clinically meaningful efficacy and enhanced bioavailability in Phase 2 and Phase 3 studies conducted by other ‘Feasibility-to-Licensing’ partners.”

“We believe Oral CR845 has the potential to bring significant relief to patients with CKD-aP,” stated Derek Chalmers, Ph.D., D.Sc., president and chief executive officer of Cara Therapeutics. “We are pleased we have been able to continue our work with Enteris and initiate this Phase 1 study with the potential to advance Oral CR845 into a Phase 2 clinical trial in CKD-aP in the first quarter of 2018.”

The Phase 1 trial is designed to examine the pharmacokinetics and safety of three tablet strengths of Oral CR845 (0.25 mg, 0.5 mg and 1.0 mg), dosed daily over a one-week treatment period in up to 80 non-hemodialysis patients with stage III-V CKD. The tablets utilize the same formulation used in the successful Phase 1 trial in hemodialysis patients with chronic kidney disease that was announced on July 12, 2017. Data from this trial will inform dose selection and design of a planned placebo-controlled Phase 2 trial of Oral CR845 in non-hemodialysis stage III-V CKD-aP patients, which the Cara Therapeutics plans to initiate in the first quarter of 2018.

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 peripheral kappa opioid receptors (KORs). Cara is developing a novel and proprietary class of product candidates, led by CR845, a first-in-class KOR agonist that targets the body’s peripheral nervous system. In Phase 2 trials, CR845 has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in patients with moderate-to-severe CKD-associated pruritus. Additionally, CR845 has also demonstrated initial signs of efficacy in patients with moderate-to-severe pain, without inducing many of the undesirable side effects typically associated with currently available opioid 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 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 most advanced internal product candidate, Ovarest™ (oral leuprolide tablet), is an oral peptide being developed for the treatment of endometriosis. In August 2017 Enteris announced the successful dosing of the first women in a Phase 2a clinical trial for endometriosis. For more information on Enteris BioPharma and its proprietary oral delivery technology, please visit

SOURCE: Entereis BioPharma