Revolo Biotherapeutics Announces the Completion of Phase 1 Multiple Ascending Dose Clinical Trial of '1104

NEW ORLEANS and CAMBRIDGE, United Kingdom, Sept. 21, 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 the completion of a Phase 1 multiple ascending dose (MAD) clinical trial evaluating the safety and tolerability of the Company’s immune-resetting drug candidate, ‘1104, in healthy volunteers.

The study showed no clinically significant adverse safety findings at any of the doses evaluated (16, 32, and 64 mg). The results support the evaluation of ‘1104 at doses above those administered in clinical trials to date.

“The positive safety profile observed across all doses of ‘1104 supports our plan to escalate the dose levels in our upcoming Phase 2b trial in patients with active eosinophilic esophagitis (EoE),” said Jonathan Rigby, Chief Executive Officer of Revolo. “The results from our recently completed Phase 2a trial in EoE showed a statistically significant improvement in patient-reported dysphagia symptoms at the combined 4 and 8 mg doses compared to placebo. We anticipate that higher doses administered over a longer duration of treatment could potentially result in a superior efficacy profile. We are working diligently to initiate a Phase 2b EoE trial in H1 2024.”