Revolo Biotherapeutics Announces US FDA Approval of IND Application for Phase 2 Trial of ‘1104 in Eosinophilic Esophagitis

NEW ORLEANS and LONDON – June 23, 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 the approval of an investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA) to evaluate ‘1104, the Company’s first-in-class peptide for the treatment of allergic diseases, in a Phase 2 trial for eosinophilic esophagitis (EoE).

“The unique aspect of ‘1104 is that it works upstream in the biological pathway that drives inflammation in allergic diseases like EoE. Our goal is to prevent the inflammation associated with EoE and do this without suppressing the immune system. This approach is novel and unlike current standard of care or other solutions in development for this patient population,” said Jonathan Rigby, Chief Executive Officer of Revolo Bio. “Our data shows that a single dose of ‘1104 reduces levels of eosinophils, lymphocytes, neutrophils and inflammatory cytokines that control inflammation in allergic disease and can increase the number of regulatory T cells, key immune cells responsible for resetting the immune system. We believe that ‘1104 has the potential to revolutionize the treatment landscape for patients with EoE in need of more effective therapeutic options, and many other allergic diseases, and we look forward to advancing this Phase 2 trial as soon as possible.”

“The mechanism of action of ‘1104 involves a novel pathway to potentially reverse allergic inflammation,” said Marc E. Rothenberg, M.D., Ph.D., Advisor to Revolo Biotherapeutics and Director of Cincinnati Center for Eosinophilic Disorders. “Patients suffering from EoE are very much in need of new therapies that can control their disease, and I am excited to see the results of this upcoming Phase 2 study, a randomized, double blind, placebo controlled trial that will evaluate the safety and efficacy of ‘1104 in adults with EoE.”

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. No approved treatments exist and standard of care includes steroids, which require frequent dosing and are associated with several unwanted side effects, such as immune suppression. Roughly one third of patients do not respond to any available treatments.

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 plans to advance ‘1104 through two Phase 2 trials: one in patients with eosinophilic esophagitis 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 further clinical development for moderate-to-severe rheumatoid arthritis and non-infectious uveitis. ‘1104 is a peptide derived from a natural immune-regulatory protein and is entering phase 2 clinical trials 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.

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