Enteris BioPharma, Inc, a biotechnology company, announced that Cara Therapeutics has successfully initiated a Phase One clinical trial of its oral formulation of CR845/difelikefalin (Korsuva) in patients with chronic liver disease (CLD). The oral tablet formulation of Korsuva was engineered using Enteris’ proprietary oral peptide and small molecule delivery technology, Peptelligence.
The oral Korsuva Phase One initiation marks the fourth clinical program involving an oral formulation of Cara Therapeutics’ CR845. Oral CR845 is also the subject of a Phase Two program in chronic pain, a Phase One program in hemodialysis chronic kidney disease, and a Phase One program in non-hemodialysis chronic kidney disease patients.
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. or injection 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 Two that Cara Therapeutics elects to pursue.
“Extending Oral CR845 into the treatment of pruritus related to liver disease further illustrates Peptelligence as a technology-of-choice for enabling the transition of peptide therapeutics from injection to oral delivery,” said Joel Tune, chief executive officer and executive chairman of Enteris BioPharma.
The FDA has conditionally accepted Korsuva as the trade name of difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.
(Source: Enteris BioPharma, Inc.)
Filed Under: Drug Discovery