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Revolo's 1104 EoE Therapy Earns FDA Orphan Drug Status for Rare Esophageal Disorder


30 January 2024

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Revolo Biotherapeutics' '1104, a novel peptide for treating eosinophilic esophagitis (EoE). Promising results from Phase 2 studies demonstrate '1104's potential in resetting the immune system. This advancement marks an important step in the treatment of EoE, a rare, chronic allergic condition.

“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” said Woody Bryan, President and CEO of Revolo Biotherapeutics.

Revolo Biotherapeutics has made significant strides with '1104. This first-in-class peptide has shown promise in resetting the immune system to achieve long-term remission in patients. Following the encouraging outcomes of their Phase 2 studies, including RVLO 121-04, the company is poised to further investigate the efficacy of '1104 in a forthcoming Phase 2b study.

Dr. Evan Dellon, M.D., MPH, Gastroenterologist, Professor of Medicine  and Principal Investigator for the Phase 2a clinical 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.”

The RVLO 121-04 study, a two-week, three-dose, Phase 2a clinical trial, provided critical insights into the peptide's efficacy and safety. Key findings included a significant improvement in patient-reported dysphagia symptoms, a reduction in eosinophils and other immune cells in esophageal tissue, and an increase in regulatory T and B cells, indicating a profound impact on the immune response in EoE.

As Revolo Biotherapeutics embarks on the Phase 2b trial in 2024, the trial aims to explore higher doses and an extended therapy duration, potentially offering a new horizon of treatment for those afflicted by eosinophilic esophagitis.

About Eosinophilic Esophagitis (EoE)

EoE is a chronic, allergic inflammatory disease that is characterized 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. If not effectively treated, patients with EoE may have difficulty swallowing, chronic pain, malnutrition, and weight loss.


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