Topline data anticipated in Q2 2023
NEW ORLEANS, LA and LONDON, UK, January 5, 2023 – 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 clinical study investigating its immune-resetting molecule, ‘1104, for the treatment of patients with allergic disease.
“The ability of ’1104 to reduce and reset the inflammatory immune response to common allergens has the potential to provide a long-awaited improvement to disease management with less frequent dosing without immunosuppression,” said Jonathan Rigby, Group Chief Executive Officer of Revolo Biotherapeutics. “Having finalized enrollment and randomization of the trial, we believe we are on track to have topline data in Q2 2023. We are very pleased with the clinical progress made with our two ‘1104 trials in 2022, this one and our recently completed trial in eosinophilic esophagitis (EoE) and continue to build confidence in the potential of this platform for the treatment of a broad range of allergic diseases.”
Professor Stephen Till, Professor of Allergy at King’s College London, and lead investigator of the study, added, “Current prescription medications used for the treatment of various allergic conditions aim to help reduce the inflammation-related effects, but patients still often suffer from debilitating symptoms which can have a major impact on quality of life. A medication that provides patients with longer-term symptom relief with less dosing and no immune suppression would be a true improvement. I look forward to evaluating how ‘1104 can help achieve this, given its upstream mechanism of action at preventing allergen-driven inflammation as shown in pre-clinical models.”
The Phase 2a randomized, double-blind, placebo-controlled, parallel-group study (NCT05098522) is designed to evaluate the safety and efficacy of ‘1104 in 60 participants with moderate to severe allergy. All participants receive six doses of either the investigational drug, ‘1104, or the matched placebo over six visits within a 12-week period.
‘1104 is a first-in-class peptide derived from a natural immune-regulatory protein, mTB Chaperonin 60.1 that is involved in resetting the immune system. Revolo Bio is advancing ‘1104 through two Phase 2 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. ‘1805 is a modified analogue of a key protein in immune function nearing initiation of a second Phase 2b clinical trial for moderate-to-severe rheumatoid arthritis and a Phase 2a clinical trial for an additional autoimmune indication. ‘1104 is a peptide derived from a natural immune-regulatory protein and has recently completed a Phase 2a 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.