Immune-resetting peptide gets orphan drug status

FDA headquarters

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Revolo Biotherapeutics’ ‘1104 to treat eosinophilic esophagitis (EoE).

EoE is a chronic, allergic inflammatory disease that is characterised by the accumulation of eosinophils in the lining of the esophagus. Inflammation caused by immune cells such as T cells and mast cells results in progressive tissue injury. ‘1104 is a first-in-class peptide that is involved in resetting the immune system.

Revolo previously announced data from RVLO 121-04, a proof-of-concept Phase IIa clinical trial evaluating the efficacy, safety and tolerability of ‘1104, in adults with active EoE. In the trial, patient-reported dysphagia median symptom scores (DSQ) showed a statistically significant improvement from baseline vs placebo that was sustained for four weeks after the last dose.

Evan Dellon, Gastroenterologist, Professor of Medicine and Adjunct Professor of Epidemiology at the University of North Carolina Chapel Hill, and Principal Investigator for the Phase IIa clinical trial, said: “’1104 is a promising EoE therapeutic with a novel mechanism of action. Based on the proof-of-concept data from the Phase IIa study, I am eager to see this molecule move forward into the next stage of development.”

The company plans to initiate a Phase IIb trial of ‘1104 in adults with active EoE in 2024. The trial will evaluate higher dose levels of ‘1104 and a longer duration of therapy.

“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,” said Woody Bryan, President and Chief Executive Officer of Revolo Biotherapeutics. “We look forward to initiating a Phase IIb study of ‘1104 in EoE later this year.”

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