Revolo Unveils Promising Preclinical Data for Sublingual '1104 in Allergy Treatment

Revolo Biotherapeutics Limited has unveiled new preclinical data that highlights the potential of its leading allergic-disease treatment candidate, ‘1104, when administered as a sublingual (SL) formulation. This novel approach involves dissolving a tablet under the tongue, showing promise in a lung model of allergic disease. The results demonstrated that ‘1104, given sublingually, produced positive outcomes on various inflammatory immune cells and markers of allergic inflammation, much like its subcutaneous (SQ) and intravenous (IV) injection forms.

The data also reinforced the unique upstream mechanism of action (MOA) of ‘1104, which helps restore immune balance by affecting both the effector and regulatory components of the immune system. This effect was observed to last for several weeks. Specifically, the sublingual administration of ‘1104 led to a reduction in inflammatory cells like eosinophils and neutrophils, comparable to the reductions seen with SQ and IV injections. Furthermore, it brought down key T2 cytokines and allergen-specific immunoglobulin (Ig)E levels similarly to the other administration routes.

Dr. Kari Brown, Chief Medical Officer at Revolo, emphasized the potential implications of this development. She mentioned that if sublingual administration proves successful in clinical settings, it could significantly impact the treatment options for individuals with eosinophilic esophagitis (EoE) and other allergic diseases. The favorable safety profile of ‘1104 across multiple Phase 1-2 clinical studies and its flexible administration routes position it as a potential first-line therapy in the future.

There is a considerable demand for new treatment options for patients with EoE and other allergic conditions. Currently, EoE treatments include chronic subcutaneous monoclonal antibodies and oral treatments that come with notable safety concerns.

Revolo’s President and CEO, Woody Bryan, highlighted that these promising oral results, along with earlier data supporting the subcutaneous formulation of ‘1104, provide a clear path forward. Revolo plans to prioritize the development of the SQ formulation of ‘1104, with a new Phase 2 study in EoE slated for 2025, and potentially extending to atopic dermatitis. Concurrently, the company will continue to gather data on the SL formulation to inform future strategies and discussions with strategic partners. The overarching goal is to offer individuals with chronic allergic conditions an effective, convenient treatment option that avoids significant side effects.

‘1104 is described as a first-in-class peptide that plays a role in restoring immune balance by uniquely affecting both regulatory and effector arms of the immune system. Revolo has advanced ‘1104 through a Phase 2a trial in eosinophilic esophagitis and a clinical mapping study in allergic rhinitis patients. The company is exploring the potential of ‘1104 for other allergic diseases while planning to advance a subcutaneous dosage form into clinical studies for EoE and other type 2 allergic conditions, alongside developing a sublingual formulation.

Revolo Biotherapeutics focuses on developing therapies that work upstream in the immune cascade to treat allergic and autoimmune diseases without suppressing the immune system as current therapies do. The company's two drug candidates, ‘1104 and ‘1805, aim to restore immune balance and prevent chronic pro-inflammatory responses associated with allergic or autoimmune diseases. The disease-agnostic MOA of Revolo's assets offers a platform for developing treatments for a range of allergic and autoimmune diseases.