The Food and Drug Administration (FDA) has granted Orphan Drug designation to OCE-205 for the treatment of hepatorenal syndrome.

OCE-205 is a mixed agonist-antagonist peptide therapeutic designed to selectively target the vasopressin 1a (V1a) receptor. The mixed V1a agonist-antagonist activity of OCE-205 is designed to relieve portal hypertension while avoiding excessive vasoconstriction.

The Company is currently evaluating the efficacy and safety of OCE-205 in a phase 2 trial (ClinicalTrials.gov Identifier: NCT05309200), in adults who have developed hepatorenal syndrome with acute kidney injury as a complication of cirrhosis with ascites.

“Receiving Orphan Drug Designation for OCE-205 underscores the urgent unmet medical need for patients with hepatorenal syndrome,” said Katherine Vega Stultz, president and CEO at Ocelot Bio. “We are actively engaged with leading medical centers to advance our phase 2 clinical study, and our team is working towards better understanding patient outcomes to continue to progress with urgency our development program for OCE-205.”

Reference

Ocelot Bio receives FDA Orphan Drug designation for OCE-205 for the treatment of hepatorenal syndrome. News release. Ocelot Bio, Inc. Accessed August 22, 2022. https://www.businesswire.com/news/home/20220819005390/en/