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

pharmafile | April 19, 2023 | News story | Business Services  

NEW ORLEANS and CAMBRIDGE, UK, April 19 2023 – 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).


Related Content

No items found

Latest content