Study data anticipated in Q2 2023
NEW ORLEANS, LA and CAMBRIDGE, England, March 27, 2023 – Revolo Biotherapeutics (“Revolo Bio” 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 the twelve-week Phase 2a clinical trial evaluating the safety and efficacy of the company’s immune-resetting drug, ‘1104, in allergic disease. The company anticipates top-line data from the study during the second quarter of 2023.
“We are pleased to have reached this relevant milestone and look forward to receiving data from the study in the near future,” said Jonathan Rigby, Chief Executive Officer of Revolo Bio. “Building on the promising pre-clinical data that has showcased ‘1104’s long-lasting and allergen-agnostic anti-inflammatory effects, we are excited by this clinical progress. We look forward to initiating a food allergy clinical study where there is a very large unmet need as a next step in the development of ‘1104.”
The Phase 2a randomized, double-blind, placebo-controlled, parallel-group study (NCT05098522) is designed to evaluate the safety and efficacy of ‘1104 in 60 patients with moderate to severe allergy. All participants received six doses of either the investigational drug, ‘1104, or 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 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 expects data readout for the EoE data in Q2 2023 and the allergen sensitivity study in Q2 2023.
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. 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.