Topline data anticipated around year-end 2022
NEW ORLEANS, LA and LONDON, UK, September 12, 2022 – 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 it has completed enrollment and has fully randomized all patients in a Phase 2a proof of concept clinical study investigating its immune-resetting molecule, ‘1104, for the treatment of patients with eosinophilic esophagitis (EoE).
“We are pleased to announce the completion of enrollment in this trial, which comes ahead of our original expectations, enabling us to anticipate topline data around the end of the year,” said Jonathan Rigby, Group Chief Executive Officer of Revolo Biotherapeutics. “Given ’1104’s ability to reset the immune system from a pro inflammatory state to a regulated homeostatic state, we believe it has great potential to eliminate the debilitating symptoms that EoE patients suffer from.”
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 clinical trial, added, “Patients with EoE are very much in need of effective and safe therapies that treat this life-changing disease. This study will inform us about how ‘1104 affects histology and the associated inflammatory biomarkers, key components of the complex physiopathology of the disease.”
The Phase 2a, randomized, double-blind, placebo-controlled trial (NCT05084963) is designed to evaluate the safety and efficacy of ‘1104 in adults with EoE. Top line data is expected around the end of 2022.
About Eosinophilic Esophagitis (EoE)
EoE is a chronic, allergic inflammatory disease that is characterized by the buildup of eosinophils in the lining of the esophagus. Patients with EoE may experience difficulty feeding, weight loss and trouble swallowing among other symptoms. In the U.S., about 180,000 children and adults live with EoE.
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. ‘1805 is a modified analogue of a key protein in immune function that is entering a second Phase 2 clinical trial for moderate-to-severe rheumatoid arthritis and a Phase 2 clinical trial for non-infectious uveitis. ‘1104 is a peptide derived from a natural immune-regulatory protein and is being evaluated in a Phase 2 clinical trial for patients with eosinophilic esophagitis (EoE) and a Phase 2 clinical trial for 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.
For further information, please visit www.revolobio.com.
Marylyn Rigby, VP Investor Relations & Marketing
Monica Rouco Molina, Ph.D.