NEW ORLEANS, LA and LONDON UK, July 30, 2021 – 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, announced today receipt of Clinical Trial Authorization (CTA) by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK to evaluate safety and efficacy of its first-in-class peptide for the treatment of allergic disease, ‘1104, in a Phase 2 allergen sensitivity study.
“Despite the ubiquity of allergic diseases, few treatments provide long-term remission and patients require frequent dosing without complete symptom relief in most cases,” said Jonathan Rigby, Chief Executive Officer of Revolo Bio. “Our pre-clinical and clinical data to date have been very encouraging, demonstrating a positive safety profile and ‘1104’s ability to reduce the number of immune cells involved in allergic inflammation and restore the levels of A20, which controls a broad range of cellular activities including cell activation and inflammatory pathways. We are excited to further demonstrate the potential of ‘1104 to change disease management and treatment experience for the diversity of patients living with allergic diseases.”
The Phase 2 randomized, double-blind, placebo-controlled, parallel-group study is designed to evaluate the safety and efficacy of ‘1104 in participants with moderate to severe grass pollen allergy. The study aims to enroll 60 subjects, of which 30 will receive 8 mg of ‘1104 intravenously once every two weeks, and the remaining 30 will receive placebo. All participants will receive an intradermal challenge, nasal allergen challenge and skin prick titration test at the onset of the study (Day 1) and at the conclusion (Day 84).
‘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.
About Revolo Biotherapeutics
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 by preventing 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 and is entering clinical development for its second Phase 2 trial in moderate-to-severe rheumatoid arthritis and a Phase 2 clinical trial in non-infectious uveitis. ‘1104 is a peptide derived from a natural immune-regulatory protein and is entering Phase 2 clinical development for patients with eosinophilic esophagitis (EoE) and 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.