Oral Korsuva enters phase 2 for treatment of PBC-related pruritus

Cara Therapeutics announced the initiation of a phase 2 trial of oral Korsuva for the treatment of pruritus in patients with hepatic impairment due to primary biliary cholangitis, according to a press release.

Korsuva (CR845/difelikefalin) is a first-in-class kappa opioid receptor agonist that targets the body’s peripheral nervous system and certain immune cells. The tablet formulation was engineered using Enteris BioPharma’s proprietary oral peptide delivery technology, Peptelligence.

“We are pleased with our ongoing work with Enteris and are excited to advance a second oral Korsuva program in a pruritis setting into phase 2,” Derek Chalmers, PhD, DSc, president and CEO of Cara Therapeutics, said in the release. “Pruritus continues to be a significant comorbidity in patients with chronic cholestatic liver diseases and may be exacerbated by certain bile acid-related drugs. We believe that oral Korsuva may provide a potential new, first-in-class therapeutic approach to treat this unmet clinical need.”

The randomized control phase 2 trial will comprise 60 patients who will receive a 1-mg tablet of the therapeutic taken twice daily for 16 weeks. The primary endpoint is the change in baseline in the weekly mean of the daily 24-hour Worst Itch Numeric Rating Scale score at end of study.

Oral Korsuva is also currently in a separate phase 2 trial for the treatment of pruritus in stage 3 to stage 4 chronic kidney disease.

“This is another significant milestone for Cara and highlights the important, ongoing relationship between Cara and Enteris,” Joel Tune, CEO and executive chairman of Enteris BioPharma, said in the release. “With Cara now actively evaluating Oral Korsuva in two separate phase 2 clinical trials ... evidence continues to mount suggesting that Peptelligence has the potential to enable the oral delivery of peptide therapeutics across multiple drug compounds and disease indications.”

Reference: www.enterisbiopharma.com