Revolo Biotherapeutics Announces Additional Data from Phase 2a Trial of ‘1104 in Adults with Active Eosinophilic Esophagitis

– Data shows statistically significant improvement in patient-reported dysphagia symptoms compared to placebo –

– Unique broad mechanistic effect across a range of key cell types associated with EoE –

– Novel findings across a range of immune cells that differentiates ‘1104 from other therapies –

NEW ORLEANS and CAMBRIDGE, United Kingdom, July 18, 2023 (GLOBE NEWSWIRE) — 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 additional data from its proof of concept, 2-week, 3-dose, 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).

The following key observations were made:

• Patient reported dysphagia median symptom scores (“DSQ”) showed a sustained statistically significant improvement from baseline vs placebo that continued for four weeks after the last dose
• Eosinophil count showed a ~50% statistically significant reduction from baseline as measured by flow cytometry
• 8mg ‘1104 showed a statistically significant ~58% increase in T regulatory cells, that act to suppress inflammatory immune responses, taken from esophageal biopsies
• 100% of patients showed an increase in activated CD95+IgD-CD27^highCD38^high (gated on CD3-CD19+) B regulatory cells that act to suppress inflammatory immune responses. The increase seen at both doses was statistically significant
• 8mg ‘1104 showed a statistically significant reduction of 14% in CD4+ and 45% in CD8+ cells in esophageal biopsies that are known to be key inflammatory cells in EoE
• Data shows positive directional changes across 15 key EoE genes considered to affect remodeling, eosinophil and mast cell count, inflammation, cell adhesion, and the epithelium lining
• Safety assessment showed no serious adverse events and there were no study drug discontinuations due to drug-related adverse events

Jonathan Rigby, Group Chief Executive Officer of Revolo Biotherapeutics said, “Simply put, the data generated in this study of ‘1104 in EoE has exceeded our expectations and the broad mechanistic effect observed positions ‘1104 in a category of its own. We are keen to initiate discussions of next steps with the FDA for the Phase 2b study that will include higher and more frequent dosing that we expect will show superior efficacy with sustained tolerability.”

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 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 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.

Company Contact
Marylyn Rigby, VP Investor Relations & Marketing
mrigby@revolobio.com

Media Contact
Monica Rouco Molina, Ph.D.
LifeSci Communications
+1-929-469-3850
mroucomolina@lifescicomms.com