Ocelot Bio gains FDA ODD for OCE-205 for ascites treatment
Betsy Goodfellow | December 21, 2023 | News story | Research and Development | Gastrointestinal tract, Ocelot Bio, ascites
Ocelot Bio has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to OCE-205 for the treatment of ascites due to all etiologies except cancer.
Ascites is “the abnormal accumulation of fluid within the peritoneal cavity of the abdomen and the hallmark of progression into the decompensated phase of cirrhosis,” according to the company’s press release.
Currently, there are limited treatment options for this indication, with many including invasive procedures with significant risks and burdens for patients.
OCE-205 is a therapeutic peptide with a “differentiated mechanism of action that has potential for improving outcomes for patients with complications of end-stage liver disease (ESLD),” according to the press release.
The company has already completed enrolment to a phase 2 clinical trial of the drug candidate, which is intended to assess its treatment of hepatorenal syndrome with acute kidney injury (KRS-AKI), with the studies expected to begin in 2024. The FDA granted ODD to the drug for hepatorenal syndrome in 2022 and in ascites in 2023.
Lise Kjems MD PhD, chief medical officer at Ocelot Bio, commented: “The FDA granting ODD for OCE-205 in ascites is validation of the tremendous need for improved therapies offering novel approaches for patients and supports our clinical focus on this important indication. This milestone serves as a catalyst as we work with patients, healthcare professionals and health authorities to pave a brighter path forward for these patients who have limited treatment options. We are well positioned to further advance our clinical development program for OCE-205 and look forward to progressing this program in ascites.”
Betsy Goodfellow
