Topline data anticipated in early 2023
NEW ORLEANS, LA and LONDON, UK, November 9, 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 the last patient has completed a Phase 2a proof of concept clinical study investigating its immune-resetting molecule, ‘1104, for the treatment of patients with eosinophilic esophagitis (EoE).
“The last patient out marks a key milestone in our Phase 2a trial in EoE, and we are looking forward to announcing topline data early next year,” said Jonathan Rigby, Group Chief Executive Officer of Revolo Biotherapeutics. “’1104 has the unique ability to reset the immune system ahead of the inflammatory cascade, providing a potentially promising new treatment option for patients without causing immunosuppression. ‘1104 stands out from other drug products that treat allergic disease by its broad effect in reducing a spectrum of key inflammatory cytokines and reduction of inflammatory immune cells, such as eosinophils, mast cells, neutrophils and lymphocytes. We are confident that the data in early 2023 will support its potential to have an improvement in symptomatic and physiologic response for EoE patients.”
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, “Despite the approval of the first treatment for EoE patients earlier this year, many are still very much in need of an effective and safe option to treat this complex and life-changing disease. Data from this study will provide insight into the safety and efficacy of ‘1104 in patients with EoE and, if positive, will inform the design of future late-stage studies. In the interest of patients, I am eager to see the data from this novel drug product.”
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 in early 2023. Contact details for Revolo Biotherapeutics are below.
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, poor weight gain 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 nearing initiation of a second Phase 2 clinical trial for moderate-to-severe rheumatoid arthritis and a Phase 2 clinical trial for an additional autoimmune indication. ‘1104 is a peptide derived from a natural immune-regulatory protein and has recently completed a Phase 2 clinical trial for patients with eosinophilic esophagitis (EoE) with topline data expected in early 2023. ‘1104 is also being evaluated in an ongoing Phase 2 clinical trial for allergic disease with data expected Q2 2023. 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.