– Treatment with ‘1104 demonstrated a rapid reduction in intradermal allergic inflammation –
– Treatment with ‘1104 induced sustained activation of T regulatory and B regulatory cells, providing additional clinical validation of its mechanism of action –
NEW ORLEANS and CAMBRIDGE, UK, October 25, 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 topline data from its allergen challenge mapping study evaluating the immunologic mechanisms, safety, and tolerability of the Company’s immune-resetting drug, ‘1104, in atopic adults with moderate to severe allergy.
The goal of the trial was to further characterize the mechanism of action of ‘1104 using an atopic population undergoing allergen challenges. The trial demonstrated that ‘1104 administration led to a rapid reduction in the allergic inflammation caused by the intradermal grass pollen challenge after the first dose of ‘1104. Relative to placebo, treatment with ‘1104 led to average wheal diameter surface area reductions of 23% and 40%, respectively, eight hours after the challenge. Consistent with the previous clinical studies of ‘1104, no adverse safety signals were observed.
The reduction in allergic inflammation was accompanied by a sustained increase in activated interleukin 10 (IL-10)+ T regulatory cells (Tregs) and IL-10+ B regulatory cells (Bregs), which are key regulatory immune cells that control the allergic response and inflammation, which persisted for at least 28 days. By week 12, Treg and Breg levels returned to baseline, due to the absence of an ongoing allergen exposure. In addition, ‘1104 led to a normalization of the levels of key inflammatory and tissue remodeling genes, which was sustained through week 12, the end of the trial.
“These new data reaffirm the broad mechanistic effects of ‘1104 in restoring the immune system balance, with the potential to drive long-term disease remission given its demonstrated sustained immune tolerance effects in diseases with continued allergen exposure,” said Jonathan Rigby, Revolo’s Chief Executive Officer. “These data, combined with previously reported positive safety and efficacy results of ‘1104 across various studies including a recent Phase 2a clinical study in eosinophilic esophagitis (EoE), reinforce the potential of ‘1104 as a groundbreaking treatment for multiple allergic diseases. We are excited to commence a Phase 2b trial for ‘1104 in EoE in the first half of 2024, as we continue to explore further indications that could benefit from ‘1104’s novel immune tolerance mechanism of action.”
The 12-week, randomized, double-blind, placebo-controlled, parallel-design, allergen challenge trial (NCT05098522) was designed to assess the immunologic mechanisms, safety, and tolerability of ‘1104 treatment in adult participants with moderate to severe seasonal allergic rhinitis. Patients (n=63) were dosed with either 8 mg of ‘1104 or placebo and were challenged with grass pollen allergen intradermally. Eight hours later, patients were evaluated for the mean diameter of the intradermal challenge late phase response (LPR) as well as other metrics of immune system response over the remainder of the study period.
‘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.