Our Approach: OCE-205

Hepatorenal syndrome with acute kidney injury (HRS-AKI)

Ocelot Bio’s lead asset is OCE-205, a therapeutic peptide with a differentiated profile that has demonstrated potential for improving outcomes for patients with complications of end-stage liver disease (ESLD).

 

We are first exploring the clinical development of OCE-205 in hepatorenal syndrome with acute kidney injury, where it offers promise for reversing renal failure and prolonging survival to enable more patients to successfully undergo liver transplantation with fewer needing combined liver and kidney transplantation. 

Differentiated Mechanism of Action

OCE-205’s innovation emanates from its design as mixed agonist-antagonist peptide selective for the vasopressin 1a (V1a) receptor with no vasopressin 2 (V2) receptor activity at drug concentrations achieved while treating ESLD. By virtue of its mixed V1a agonist/antagonist activity, OCE-205 treatment is designed to relieve portal hypertension while offering a capped maximal efficacy that avoids excessive vasoconstriction seen with full agonists, which may lead to ischemic events. By eliminating V2 activity, OCE-205 treatment is designed to potentially avoid the fluid retention and overload. By virtue of its submaximal agonism and selectivity, OCE-205 harnesses a proven mechanism of action for the treatment of HRS-AKI while addressing the limitations of existing agents.

Foundation of Data Supports Phase 2 Trial

In Phase 1 clinical evaluation of OCE-205, healthy subjects demonstrated predicted vasoconstriction activity in a dose-response manner along with the anticipated changes in mean arterial pressure as well as a promising safety profile.

 

Based on this mechanistic data, preclinical and Phase 1 clinical data, Ocelot Bio has initiated a Phase 2 clinical trial of OCE-205 in HRS-AKI. The study is designed as a placebo-controlled, dose ranging trial of OCE-205 in HRS-AKI.

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