Revolo Biotherapeutics Limited (“Revolo”) today announced new data from preclinical studies and previously completed clinical trials that further elucidate the upstream mechanism of action (MOA) of ‘1104, which uniquely affects both the effector and regulatory arms of the immune response.

The data confirms that ‘1104 binds to a novel receptor through selective upstream binding to allergic antigen-presenting cells (APCs) which reduces IL-4 and IL-13 signaling pathways. ‘1104 also rapidly upregulates activated T regulatory (Tregs) and activated B regulatory cells (Bregs) for multiple weeks, which can restore immune homeostasis and support less frequent dosing regimens.

Additional positive animal data assessing a subcutaneous (SC) dosage form of ‘1104 verifies the continued development of a differentiated SC commercial formulation. In animal models of allergic disease, ‘1104 SC delivery performed as well as intravenous administration. The newly generated data validates the prioritization of the ‘1104 SC development program, with plans to initiate bridging clinical studies in 2025.

“It is well documented that targeted downstream therapies can fail to translate eosinophil reduction at the tissue-level into meaningful clinical responses, creating a large unmet need for novel therapies,” said Kari Brown, Executive Vice President of Clinical Development, Operations and Strategy at Revolo. “We are excited to shed more light on the upstream signaling pathways engaged by ‘1104 which show its ability to engage the effector and regulatory arms of the immune response. These new data demonstrate the potential of ‘1104 to treat a range of allergic diseases.”

Woody Bryan, President and Chief Executive Officer of Revolo, added, “At Revolo, our priority has been to develop a differentiated product for patients with allergic diseases. The SC administration of ‘1104 will offer a patient-friendly treatment. Additionally, based on encouraging animal data, we are evaluating the potential for sublingual administration, which will further elevate the competitive commercial profile of ‘1104 and improve patient convenience. We look forward to sharing data in the future.”

Previously announced positive data that supports the clinical potential of ‘1104 include:In a Phase 2a clinical trial (RVLO 121-04) evaluating the efficacy, safety, and tolerability of ‘1104 in adults with active eosinophilic esophagitis (EoE):

• Treatment with ‘1104 led to a statistically significant separation from baseline in key clinical endpoints and a rapid translation into a clinical response per the patient-reported outcome of the Dysphagia Severity Questionnaire (DSQ).
• The data substantiates that 1104’s upstream MOA offers a first-in-class modality that overcomes the shortfall of other downstream approaches that have impacted histologic endpoints but failed to show clinical response.

In a Phase 2a trial mapping study in allergic individuals subjected to nasal and skin allergen challenges (RVLO 121-05) data demonstrated:

• Rapid reduction (Day 1) in intradermal allergic inflammation.
• Sustained activation of Tregs and Bregs, providing additional clinical validation of its MOA with persistence to at least 28 days.

About ‘1104‘1104 is a first-in-class peptide that is involved in restoring immune homeostasis. Revolo 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. Revolo is planning to advance a commercially differentiated SC dosage form into clinical studies for EoE and other type 2 allergic conditions.

About Revolo BiotherapeuticsRevolo is developing therapies that work upstream in the immune cascade for the treatment of autoimmune and allergic diseases, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1805 and ‘1104, a protein and a peptide respectively, restore immune homeostasis to prevent the chronic pro-inflammatory immune response that results in autoimmune or allergic disease. 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.

Company ContactWoody Bryan, Ph.D.President and CEOwbryan@revolobio.com

Media ContactMichael RubensteinLifeSci Communications+1 561-289-7981mrubenstein@lifescicomms.com