Enteris BioPharma Highlights Progress in Oral Feasibility Program

Enteris BioPharma, Inc. recently provided an update on its oral feasibility programs involving the company’s Peptelligence and ProPerma oral peptide and small molecule delivery technologies.

“During 2021, Enteris initiated six oral feasibility programs involving peptide and small molecule drugs targeting a variety of therapeutic indications that include cancer, women’s health and disorders of the central nervous system. We anticipate some of these will transition to more extensive agreements in the near future,” said Rajiv Khosla, PhD, Chief Executive of Enteris. “These partners range from emerging biotechnology firms to large, established pharmaceutical companies, illustrating the vast potential of Enteris’ Peptelligence and ProPerma technology platforms and our ability to partner with companies that want to resolve the bioavailability constraints of their new chemical entity, extend a mature product’s life cycle, or achieve better manufacturing and scale-up process by formulating those drugs for oral delivery.”

Dr. Khosla continued “In a feasibility program, Enteris applies our Peptelligence platform to a client’s peptide-based drug, or the ProPerma platform for a small molecule, to determine the potential of developing oral tablet formulations. We provide clients with optimized tablet prototypes, specifically tailored to the client’s API, which are evaluated in preclinical PK studies. Once proof-of-concept is confirmed, we then advance the agreement to support the formulation, manufacturing, and clinical development of the solid oral tablet drug, from Phase 1 through to Phase 3 and potential commercialization.”

Peptelligence is designed to enhance the oral delivery and bioavailability of peptide-based drugs by enhancing the permeability of such compounds and preventing their breakdown in the digestive tract. ProPerma improves the oral delivery of BCS class III and IV small molecules by improving the compounds’ solubility and permeability. Enteris has demonstrated positive results in enhancing the oral bioavailability of BCS-III and BCS-IV small molecules, in some cases providing more than 20-fold improvement in oral bioavailability.

Enteris’ oral delivery technologies have been the subject of numerous feasibility studies and active internal and external development programs. This includes Cara Therapeutics’ ongoing development of CR845/difelikefalin (Oral KORSUVA), an oral formulation of Cara’s first-in-class KOR agonist, which was initially developed via an oral feasibility program. Oral KORSUVA is currently the subject of four separate late-stage clinical trials for pruritus in patients with hepatic impairment due to primary biliary cholangitis (PBC), stage III-V non-dialysis dependent (NDD) chronic kidney disease (CKD), atopic dermatitis (AD) and notalgia paresthetica. In June and December 2021, Enteris announced the receipt of two separate milestone payments from Cara totaling $15 million per the definitive licensing agreement for Peptelligence. Since license inception Enteris has received $28 million in receipts from Cara. Enteris is eligible to receive additional potential milestone payments, subject to the achievement of certain development milestones for Oral KORSUVA, of which Enteris will retain half.

Enteris BioPharma, Inc. is a wholly owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH) offering total integrated contract development and manufacturing (CDMO) services including innovative formulation solutions utilizing its proprietary drug delivery technologies, Peptelligence and ProPerma. The technologies have been the subject of numerous feasibility studies and active development programs, several of which are in clinical development. Additionally, Enteris BioPharma is advancing an innovative internal product pipeline of drug products that address significant unmet clinical needs for which there is no satisfactory treatment option. For more information, visit http://www.EnterisBioPharma.com.