Revolo Biotherapeutics Announces Completion of Phase 2a Trial of ‘1104 in Allergic Disease

pharmafile | March 27, 2023 | News story | Business Services  

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.


About ‘1104

‘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.

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