FDA grants ODD to Revolo Biotherapeutics’ eosinophilic esophagitis treatment
Betsy Goodfellow | February 1, 2024 | News story | Medical Communications | FDA, ODD, Pharmacy, Revolo Biotherapeutics, eosinophilic esophagitis
Revolo Biotherapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ‘1104, a first-in-class immune-resetting peptide in development for the treatment of eosinophilic esophagitis (EoE).
The company submitted its request before beginning its phase 2a EoE study, RVLO 121-04, followed by an amended request following positive results from an additional phase 2 study.
The company has previously shared results from RVLO 121-04 which assessed the efficacy, safety and tolerability of ‘1104 in adults with active EoE. It was demonstrated that there was a statistically significant improvement in patient-reported dysphagia median symptom scores (DSQ), reduction in eosinophils, CD4+ and CD8+ cells, and increase in T regulatory cells in esophageal tissue and B regulatory cells in the blood.
Woody Bryan, president and chief executive officer of Revolo Biotherapeutics, commented: “We are excited that the FDA has granted ODD for ‘1104 in EoE, as there remains a significant unmet need for new treatment innovations for people living with this disease. We look forward to initiating a phase 2b study of ‘1104 in EoE later this year.”
Evan Dellon MD MPH, gastroenterologist, professor of medicine and adjunct professor of Epidemiology at the University of North Carolina Chapel Hill, US, and principal investigator on the trial, added: “’1104 is a promising EoE therapeutic with a novel mechanism of action. Based on the proof-of-concept data from the Phase 2a study, I am eager to see this molecule move forward into the next stage of development.”
Betsy Goodfellow
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