Our Approach: Pipeline

OCE-205: Advancing to Transform ESLD Treatment

We’re harnessing our innovative scientific approach and the differentiated profile of our unique therapeutic peptide, OCE-205, to transform the treatment of end-stage liver disease (ESLD). Our team is making important progress in our mission to deliver new therapeutic options that offer promise for improving outcomes for patients with life-threatening consequences of ESLD.

 

OCE-205 is currently in Phase 2 clinical development for HRS-AKI, where it offers potential for reversing acute renal injury and prolonging survival to enable more patients to successfully undergo liver transplantation with fewer needing combined liver and kidney transplantation. In Phase 1 clinical evaluation of OCE-205, healthy subjects demonstrated vasoconstriction activity in a dose-response manner along with the desired changes in mean arterial pressure with a promising safety profile.

 

We are also in early-stage development of OCE-205 for the treatment of ascites, a complication of ESLD-induced portal hypertension that leads to the accumulation of fluid in the peritoneal cavity. Ascites profoundly diminishes quality of life and is indicative of a much poorer prognosis for patients struggling with ESLD.

OCE-205 for HRS-AKI Phase 2 Study

 

Based on our strong body of mechanistic, preclinical and Phase 1 clinical data, Ocelot Bio has initiated a Phase 2 clinical trial of OCE-205 in HRS-AKI. Further, the U.S. Food & Drug Administration (FDA) has granted OCE-205 Orphan Drug Designation in the treatment of hepatorenal syndrome. The dose-ranging, Phase 2 study has the overall objective of obtaining safety and efficacy data, as well as PK and PD characteristics of OCE-205 in the target population of adults diagnosed with cirrhosis with ascites who have developed HRS-AKI. Learn More >

Indication

Preclinical

Phase 1

Phase 2

Phase 3