The positive safety profile supports dosing of ‘1104 at higher doses in upcoming Phase 2b trial in EoE
NEW ORLEANS and CAMBRIDGE, UK, September 21, 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 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.”
The randomized, double-blind, placebo-controlled Phase 1 clinical trial (NCT05921591) included 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 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.
About 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.
Marylyn Rigby, VP Investor Relations & Marketing
Monica Rouco Molina, Ph.D.