Cara Therapeutics Enters Commercial License Agreement With Enteris BioPharma

Cara Therapeutics, Inc. recently announced it has entered into a non-exclusive commercial license agreement with Enteris BioPharma, Inc. for oral formulation rights to Enteris’ Peptelligence Technology.

“We are pleased to take another important step in advancing Oral KORSUVA as a potential novel treatment for chronic pruritus by entering into this commercial formulation license,” said Derek Chalmers, PhD, DSc, President and Chief Executive Officer of Cara Therapeutics. “With three ongoing Phase 2 trials across a range of patient populations for whom pruritus remains a significant unmet need, we are now well positioned to continue Oral KORSUVA’s development and potential future commercialization.”

Under the terms of the License Agreement, Enteris granted Cara a non-exclusive license to its Peptelligence Technology to develop and commercialize Oral KORSUVA in any indication worldwide, excluding South Korea and Japan. Enteris will receive an upfront payment of $8 million, including $4 million in cash and $4 million in Cara common stock. Enteris is also eligible to receive development, regulatory and tiered commercial milestone payments, as well as low, single-digit royalties based on net sales in the licensed territory. Cara retains the right to buy out the royalty obligation for a period of two years under prespecified conditions.

Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA (CR845/difelikefalin), a first-in-class KOR agonist that targets KORs located in the peripheral nervous system, and on immune cells. In a Phase 3 and two Phase 2 trials, KORSUVA (CR845/difelikefalin) Injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in pruritus-related quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP), and is currently being investigated in Phase 3 trials in hemodialysis patients with CKD-aP. Oral KORSUVA is in Phase 2 trials for the treatment of pruritus in patients with chronic kidney disease, atopic dermatitis, and primary biliary cholangitis.

The FDA has conditionally accepted KORSUVA as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.