Pharma Focus Europe

Revolo Biotherapeutics Unveils New Phase 2a Trial Findings of '1104 in Adults With Active Eosinophilic Esophagitis

Wednesday, July 19, 2023

Revolo Biotherapeutics has unveiled additional data from its Phase 2a clinical trial investigating the effectiveness, safety, and tolerability of their immune-resetting drug, '1104, in adults with active eosinophilic esophagitis (EoE), a chronic allergic inflammatory disease characterized by eosinophil accumulation in the esophagus lining. The study comprised three groups: '1104 at Dose A, '1104 at Dose B, and a placebo group, with all subjects receiving treatment once weekly for three weeks.

Key findings from the trial include:

  1. Significant and sustained improvement in patient-reported dysphagia symptom scores compared to the placebo, which persisted for four weeks after the final dose.
  2. A statistically significant ~50% reduction in eosinophil count from baseline, as measured by flow cytometry.
  3. '1104 at 8mg showed a statistically significant ~58% increase in T regulatory cells, responsible for suppressing inflammatory immune responses, as observed in esophageal biopsies.
  4. All patients exhibited an increase in activated B regulatory cells that suppress inflammatory immune responses, with the increase being statistically significant at both dosages.
  5. '1104 at 8mg led to a statistically significant reduction of 14% in CD4+ and 45% in CD8+ cells, which are crucial inflammatory cells in EoE, in esophageal biopsies.
  6. Positive directional changes were observed across 15 key EoE genes affecting various aspects of the disease.
  7. Safety assessments showed no severe adverse events, and there were no study drug discontinuations due to drug-related adverse effects.

Jonathan Rigby, Group Chief Executive Officer of Revolo Biotherapeutics, expressed enthusiasm about the study's outcomes and plans to engage in discussions with the FDA for a Phase 2b study, involving higher and more frequent dosing of '1104, with the expectation of achieving superior efficacy and sustained tolerability.

Evan Dellon, M.D., MPH, the Principal Investigator for the clinical trial, also expressed optimism about the broader mechanistic data from the study, which potentially positions '1104 as a safe and effective therapy for EoE, considering its complex disease pathology.

The Phase 2a trial was randomized, double-blind, and placebo-controlled, involving a total of 36 participants. It is estimated that EoE affects around 180,000 children and adults in the United States.

'1104 is a first-in-class peptide designed to reset the immune system, and Revolo Bio has been exploring its potential in treating EoE and other allergic diseases through Phase 2a trials.

Overall, the results from the Phase 2a trial show promising efficacy and safety for '1104 in treating EoE, and Revolo Biotherapeutics looks forward to further evaluating its potential in subsequent clinical studies.

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