The contract development and manufacturing organization (CDMO) Enteris BioPharma received a $10 million milestone payment from Cara Therapeutics related to the license agreement for the Peptelligence oral formulation technology utilized in Oral KORSUVA—the oral formulation of Cara’s first-in-class KOR agonist, CR845/difelikefalin. Enteris is entitled to retain $3.9 million of this payment per the contractual splits agreed to in the Enteris acquisition agreement with its parent, SWK Holdings.
 
This milestone payment was triggered by confirmation from Cara of the completion of an End-of-Phase 2 Meeting with the U.S. FDA for Oral KORSUVA in patients with non-dialysis dependent (NDD) chronic kidney disease (CKD-aP). Cara has indicated that it currently plans to initiate a Phase 3 program by year-end 2021. Enteris received two previous milestone payments totaling $5 million during the fourth quarter of 2020 of which Enteris retained $3 million. Enteris is eligible to receive additional potential milestone payments over the next several quarters, subject to the achievement of certain development milestones for Oral KORSUVA.
 
“This is the third and largest milestone payment generated by the Cara Therapeutics licensing agreement for Oral KORSUVA, validating Enteris’ ability to produce value for its pharmaceutical partners and SWK’s shareholders,” said Winston Black, chairman and CEO, SWK Holdings. “The milestones generated from the Cara licensing agreement also highlight the ongoing potential to monetize Enteris’ Peptelligence and ProPerma technologies, given the numerous market and patient advantages of developing oral tablet formulations of peptides and small molecules.  Enteris’ oral delivery technologies, combined with its manufacturing capacity and CDMO capabilities, make it a potentially attractive partner to a range of pharmaceutical and biotechnology companies.”
 
Oral KORSUVA was engineered using Enteris’ Peptelligence technology, which is designed to enable the oral delivery of peptides and BCS class II, III and IV small molecules. Oral KORSUVA is currently the subject of four separate clinical programs for pruritus in patients with hepatic impairment due to primary biliary cholangitis (PBC), stage III-V chronic kidney disease (CKD), atopic dermatitis (AD) and notalgia paresthetica (NP). These programs have multiple milestones anticipated to be achieved throughout 2021, including top line Phase 2 data from the PBC program and the initiation of a Phase 3 trial in atopic dermatitis.
 
In August 2019, Enteris and Cara entered into a licensing agreement whereby Enteris granted to Cara a non-exclusive, royalty-bearing license to the Peptelligence technology to develop, manufacture and commercialize Oral KORSUVA worldwide, excluding Japan and South Korea.  Enteris is eligible to receive milestone payments upon the successful achievement of certain development, regulatory and commercial milestones and low single-digit royalties based on net sales in the licensed territory.