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November 4, 2022
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
SAN DIEGO, CALIF. – (November 4, 2022) – 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.
“The Phase 1 data presented at AASLD provide valuable information that will inform our clinical development strategy for OCE-205. These data that demonstrate the investigational compound’s unique potential of a selective V1a receptor agonism that has a therapeutic window that is capped below maximal vasoconstrictive effects,” said Stan Bukofzer, M.D., chief scientific and medical officer at Ocelot Bio. “Ultimately, our goal is to meaningfully improve treatment options for common systemic hemodynamic complications associated with ESLD. These data support further clinical development of OCE-205 as a potential treatment for conditions such as HRS-AKI and ascites.”
Titled “OCE-205, a Novel, Selective Vasopressin (V1a) Receptor Mixed Agonist-Antagonist: Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics from a Phase 1 Study” (#3622), Ocelot Bio’s poster will be presented by Geoff Harris, DVM, Ph.D., founder of Ocelot Bio, on Sunday, November 6, 2022, at 1:00 p.m. Additionally, the poster has been selected for inclusion in the Portal Hypertension Special Interest Group (SIG) poster debrief on Sunday, November 6, at 8:00 a.m. The full poster presentation will also be made available to registered meeting attendees via The Liver Meeting Digital Experience™ within 72 hours of presentation, and the poster is now available online on the Publications page at Ocelot Bio’s website.
Ocelot Bio’s lead asset, OCE-205, is a therapeutic peptide with a differentiated mechanism of action that has potential for improving outcomes for patients with complications of ESLD. OCE-205’s innovation emanates from its design as a mixed agonist-antagonist peptide selective for the vasopressin 1a (V1a) receptor with no vasopressin 2 (v2) receptor activity at drug concentrations well above those used in 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, that leads to ischemic injury and potentially other serious adverse events such as respiratory failure. By eliminating V2 activity, OCE-205 treatment is designed to avoid fluid retention and overload.
Ocelot Bio is currently enrolling patients in its Phase 2 clinical trial evaluating OCE-205 for the treatment of HRS-AKI (NCT05309200) and has received Orphan Drug Designation for OCE-205 in the treatment of hepatorenal syndrome from the U.S. Food and Drug Administration (FDA). OCE-205 is also in early-stage development for the treatment of ascites, a complication of ESLD-induced portal hypertension that leads to the accumulation of fluid in the peritoneal cavity.
About Ocelot Bio
Ocelot Bio is a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics designed to significantly improve outcomes for patients with liver disease. The company’s lead clinical candidate, OCE-205, is a peptide therapeutic with a mechanism of action designed to selectively target complications of portal hypertension, such as hepatorenal syndrome with acute kidney injury (HRS-AKI), a serious and life-threatening consequence of end-stage liver disease (ESLD). The company was founded by leading experts in peptide therapeutic development and is backed by a strong syndicate of investors including Venrock, RA Capital Management and Vivo Capital.