Revolo Biotherapeutics Activates Clinical Sites and Opens Enrollment in a Phase 2 Clinical Trial of ‘1104 in Eosinophilic Esophagitis

NEW ORLEANS, U.S. and LONDON UK. – October 28, 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 that it has activated clinical trial sites and opened enrollment in a Phase 2 clinical trial evaluating their first-in-class peptide for the treatment of allergic diseases, ‘1104, in patients with eosinophilic esophagitis (EoE).

“This is great progress for our revolutionary company with the initiation of this Phase 2 study that represents a significant milestone in our effort to evaluate the overall potential of ‘1104 to revolutionize the treatment of allergic diseases such as EoE,” said Jonathan Rigby, Chief Executive Officer of Revolo Bio. “We look forward to demonstrating ‘1104’s ability to improve EoE symptoms through the reduction of inflammatory cells such as eosinophils in the esophagus wall. ‘1104 does this via its novel mechanism of action that resets the immune system from a pro-inflammatory state to a regulated homeostatic state, without suppressing the immune system. Currently, there are no approved therapies for people living with EoE. There is a need for effective treatment options, and we are working to complete this study as soon as possible with the goal of providing these patients with an effective medicine to improve the management of their debilitating disease.”

The Phase 2, randomized, double-blind, placebo-controlled trial 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 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 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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Company Contact

Marylyn Rigby, VP Investor Relations & Marketing

Media Contact

Monica Rouco Molina, Ph.D.
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