– Data shows achievement of primary endpoint of decreasing esophageal intraepithelial eosinophil count and positive impact on an array of histological measures of EoE –

– Favorable safety and tolerability profile consistent with Phase 1 trial results –

NEW ORLEANS, LA, USA and CAMBRIDGE, UK I April 19, 2023 I Revolo Biotherapeutics (“Revolo” 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 positive topline data from its proof of concept Phase 2a clinical trial evaluating the efficacy, safety, and tolerability of the company’s immune-resetting drug, ‘1104, in adults with active eosinophilic esophagitis (EoE).

Despite the short duration of treatment, patients treated with ‘1104 showed a dose dependent numeric reduction from baseline in the peak esophageal intraepithelial eosinophil count compared to the placebo group. In addition, ‘1104 treated patients showed positive results on a broad array of other biologic measures thought to be key drivers of EoE. Importantly, ‘1104 treated patients showed an increase in both Regulatory B cells (Bregs) and Regulatory T cells (Tregs) that act to suppress inflammatory immune responses. These findings have not been reported for any other mechanism in EoE.

This mechanistic dataset is further enhanced by an EoE specific gene expression panel which showed positive changes in expression of key EoE related genes with ‘1104 treatment. Finally, the safety assessment showed no serious adverse events, no study drug discontinuations due to adverse events, and no increase in overall adverse event rates in ‘1104-treated patients relative to those treated with placebo.

“We are extremely encouraged by the positive data observations including novel findings that distinguish ‘1104 from other EoE therapies,” said Jonathan Rigby, Group Chief Executive Officer of Revolo Biotherapeutics. “These data highlights the impact of ‘1104 across multiple pathologic mechanisms related to the underlying disease and are supported by positive changes in related EoE genes. We very much look forward to continuing to advance ‘1104 for the treatment of patients suffering from EoE, which remain in need of treatment options.”

Evan Dellon, M.D., MPH, Gastroenterologist, Professor of Medicine and Adjunct Professor of Epidemiology at the University of North Carolina Chapel Hill, and Principal Investigator for the clinical trial, added, “EoE is not just caused by eosinophils, the disease pathology is much more complex and the broader objective mechanistic data from this study is very encouraging with novel findings that potentially distinguish ‘1104 as a safe and effective therapy. This study supports further clinical evaluation of ‘1104 to treat EoE.”

The Phase 2a, randomized, double-blind, placebo-controlled trial (NCT05084963) is designed to evaluate the safety and efficacy of ‘1104 in adults with EoE. It is comprised of three arms: ‘1104 at Dose A (n=12), ‘1104 at Dose B (n=12) and the placebo group (n=12) all receiving ‘1104 or placebo intravenously once weekly for three weeks (days 0, 7, and 14 of the treatment periods), with a full treatment period of four weeks (30 days).

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.

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 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 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.

SOURCE: Revolo Biotherapeutics