Cara Therapeutics has dosed its first patient in a Phase I clinical trial of its oral formulation of CR845/difelikefalin (Korsuva) for the treatment of chronic liver disease (CLD).
It marks the fourth clinical program that involves an oral formulation of CR845.
The trial aims to study the pharmacokinetics and safety of twice-daily tablet of Korsuva in up to 60 patients with CLD.
As part of the trial, up to 12 matched healthy control subjects will be dosed over an eight-day treatment period in patients with mild, moderate or severe CLD based on their Child-Pugh classification (Class A, B and C).
Furthermore, PK and safety tolerability will be examined with Korsuva up to 5mg tablet strength in mild and moderate CLD patients.
Cara Therapeutics president and CEO Derek Chalmers said: "We believe that Oral KORSUVA has the potential to bring significant relief to patients suffering from CLD-associated pruritus.
"We are pleased to continue our work with Enteris and initiate this new Phase I study with the potential to advance oral CR845 into a Phase II clinical trial for an important indication.”
Cara Therapeutics developed the oral formulation of Korsuva by using Enteris BioPharma’s proprietary oral peptide and small molecule delivery technology, Peptelligence. The companies signed a manufacturing and clinical supply agreement for the development process.
Enteris BioPharma CEO and executive chairman Joel Tune said: “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.
“In multiple mid to late-stage clinical studies, including our internally developed assets, Peptelligence facilitated peptides have been shown to be safe and well tolerated and have demonstrated clinically meaningful efficacy and enhanced bioavailability.”
Cara Therapeutics is a partner of Enteris BioPharma’s ‘Feasibility-to-Licensing’ programme, under which Enteris BioPharma will continue to manufacture the oral formulation of Korsuva for current and potential future studies through Phase II trials that Cara Therapeutics elects to pursue.