Pharma Focus Europe

Revolo Biotherapeutics Completes Phase 1 Multiple Ascending Dose Clinical Trial of '1104

Friday, September 22, 2023

Revolo Biotherapeutics, a company dedicated to developing therapies aimed at resetting the immune system for achieving long-term remission in patients with autoimmune and allergic diseases, has announced the successful completion of a Phase 1 multiple ascending dose (MAD) clinical trial assessing the safety and tolerability of their novel immune-resetting drug candidate, '1104, in a group of healthy volunteers.

The study findings revealed no significant adverse safety concerns at any of the doses tested (16, 32, and 64 mg). These results provide strong support for the consideration of higher doses of '1104 in future clinical trials, surpassing the dosages administered in previous studies.

Jonathan Rigby, who serves as the Chief Executive Officer of Revolo, expressed optimism, stating, "The favorable safety profile observed across all '1104 doses encourages us to explore higher dose levels in our upcoming Phase 2b trial involving patients with active eosinophilic esophagitis (EoE). Our recent Phase 2a trial in EoE demonstrated a statistically significant improvement in patient-reported dysphagia symptoms at combined 4 and 8 mg doses compared to a placebo. We believe that using higher doses over an extended treatment duration could potentially yield even more promising efficacy results. Our aim is to initiate the Phase 2b EoE trial in the first half of 2024."

The Phase 1 clinical trial was conducted in a randomized, double-blind, placebo-controlled manner under the registration number NCT05921591. It involved a total of 24 healthy volunteers, who received two doses of either 16, 32, or 64 mg of '1104 or a matching placebo via intravenous (IV) bolus.

'1104 is an innovative peptide that plays a pivotal role in resetting the immune system. Revolo Bio has recently progressed '1104 through two Phase 2a trials, one involving patients with eosinophilic esophagitis (EoE) and the other focusing on patients with allergen sensitivity, all while exploring its potential for addressing various allergic diseases.

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