Ocelot Bio Presents Phase 1 Data Highlighting Activity and Safety of OCE-205 at AASLD The Liver Meeting®

In healthy volunteers, OCE-205 administration led to increases in mean arterial pressure with promising safety profile

Study findings support clinical program for OCE-205 in End-Stage Liver Disease focused on treating consequences associated with complications of portal hypertension, such as HRS-AKI and ascites

Excerpt from the Press Release:

SAN DIEGO–(BUSINESS WIRE)–Ocelot Bio, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics to treat complications of end-stage liver disease (ESLD), today announces results from the completed Phase 1 healthy volunteer clinical trial for its lead candidate, OCE-205, via a poster presentation at the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting^®, taking place in Washington, DC.

OCE-205 is an investigational vasopressin (V1a) receptor mixed agonist-antagonist therapeutic peptide that has a mechanism of action designed to selectively target consequences of the systemic hemodynamic complications associated with decompensated liver cirrhosis, or ESLD.

In the double-blinded, placebo-controlled Phase 1 study, 64 healthy volunteers ages 18-45 were randomized to placebo or one of five OCE-205 doses (0.1 mg, 0.3 mg, 0.45 mg, 0.6 mg or 0.9 mg). OCE-205 was administered as a six-hour constant rate intravenous infusion. Across the dose range studied, OCE-205 serum levels (AUC and Cmax) were dose proportional. OCE-205 administration also led to increases in mean arterial pressure (ranging from 12 to 14 mmHg) at every dose level, but the increases were not dose-proportional. The drug was well tolerated across all doses. During the study, no serious adverse events (SAEs) occurred, and most adverse events (AEs) were gastrointestinal in nature and generally mild or moderate in severity.

Click the button below to read the entire Press Release:

Continue Reading The Press Release