GAITHERSBURG, MD and CAMBRIDGE, UK, January 30, 2024 – Revolo Biotherapeutics (“Revolo” or the “Company”), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study.
The FDA grants ODD status to support the development and evaluation of potential new medicines intended for the treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Revolo believes that this ODD reflects the potential for ‘1104 to address a critical unmet need for people living with EoE.
“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 2b study of ‘1104 in EoE later this year.”
Evan Dellon, M.D., MPH, Gastroenterologist, Professor of Medicine and Adjunct Professor of Epidemiology at the University of North Carolina Chapel Hill, 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.”
Revolo previously announced data from RVLO 121-04, a proof of concept, two-week, three-dose, Phase 2a clinical trial evaluating the efficacy, safety, and tolerability of ‘1104, in adults with active EoE. The following key observations were made:
- 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.
- A statistically significant reduction in eosinophils, CD4+, and CD8+ cells from baseline as measured in esophageal tissue by flow cytometry.
- A statistically significant increase in T regulatory cells in esophageal tissue and B regulatory cells in the blood, respectively.
Based on the results from RVLO 121-04, Revolo plans to initiate a Phase 2b 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.
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.
‘1104 is a first-in-class peptide that is involved in resetting the immune system. Revolo Bio has recently advanced ‘1104 through two Phase 2a trials: one in patients with eosinophilic esophagitis (EoE) and one in patients with allergen sensitivity while exploring its potential for other allergic diseases.
Revolo Biotherapeutics is developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic disease, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1805 and ‘1104, a protein and a peptide respectively, reset the immune system to prevent the chronic pro-inflammatory immune response that results in autoimmune or allergic disease. The disease-agnostic mechanism of action of Revolo Biotherapeutic’s assets provides a potential platform for the development of treatments for multiple autoimmune and allergic diseases. ‘1805 is a modified analogue of a key protein in immune function nearing initiation of Phase 2 clinical trial in patients with moderate-to-severe rheumatoid arthritis and a Phase 2a clinical trial for an additional autoimmune indication. The disease-agnostic mechanism of action of Revolo Biotherapeutic’s assets provides a potential platform for the development of treatments for multiple autoimmune and allergic diseases.
For further information, please visit www.revolobio.com.
Woody Bryan, Ph.D.
President and CEO
Monica Rouco Molina, Ph.D.