‘1104 sublingual formulation achieved extensive systemic exposure and demonstrated impact across measures of disease in additional preclinical studies in atopic dermatitis
Sublingual formulation and novel upstream mechanism of action for ‘1104, supported in Phase 2 trials with IV formulation, offers differentiated product profile and expanding target patient market in eosinophilic esophagitis (EoE), atopic dermatitis (AD) and other allergic disease patients
Sublingual formulation expected to enter the clinic in 2026
GAITHERSBURG, MD and CAMBRIDGE, UK, August 5, 2025 — Revolo Biotherapeutics Limited (“Revolo”) today announced its decision to accelerate the advancement of a sublingual, placed under the tongue tablet, formulation of ‘1104 into the clinic. This decision is driven by positive preclinical data and a differentiated upstream mechanistic profile that has been demonstrated in Phase 2 trials with an intravenous (IV) formulation.
New preclinical data demonstrate that when administered sublingually in a model of atopic dermatitis, ‘1104 achieves rapid and extensive levels of systemic exposure with positive results across multiple clinical measures, including visual evidence of reductions in skin inflammation and inflammatory and immune markers of allergic inflammation. These results were consistent with the efficacy profile observed with subcutaneous (SQ) or IV injections of ‘1104 in previous preclinical data in atopic dermatitis (AD) and lung inflammation models.
“A sublingual therapy would provide a patient-friendly approach for managing allergic diseases such as eosinophilic esophagitis and atopic dermatitis, offering a convenient alternative to more invasive treatment modalities.,” said Kari Brown, M.D., Chief Medical Officer of Revolo Biotherapeutics. “Conversations with physicians have highlighted that a sublingual option would better align with patient preferences, potentially leading to earlier use in the treatment paradigm as many patients favor oral treatments over injectables.”
Woody Bryan, Ph.D., President and Chief Executive Officer of Revolo Biotherapeutics, added, “We believe our new focus on accelerating the oral formulation of ‘1104 creates an opportunity for a transformational product profile. As far as we know, there is no other candidate in advanced clinical development that is orally administered and targets the immune cascade upstream, driving restoration of immune homeostasis. It also has a favorable safety profile, as demonstrated in multiple Phase 2 clinical studies in allergic diseases, including eosinophilic esophagitis. We look forward to accelerating its development as we expect to enter the clinic with the sublingual formulation of ‘1104 in 2026.”
Evan Dellon, M.D., MPH, Gastroenterologist, Professor of Medicine and Adjunct Professor of Epidemiology at the University of North Carolina Chapel Hill, and Principal Investigator for Revolo’s previous clinical trials of ‘1104 in eosinophilic esophagitis (EoE), added, “An oral treatment for EoE is novel and could represent an innovative way to approach first-line therapy in the condition. Given that blood levels of the oral formulation approach those of the medication given via IV administration, the potential to dose ‘1104 in a convenient, patient-friendly delivery system is extremely promising.”
There are only two currently approved products for the treatment of EoE in the United States, including a weekly administered monoclonal antibody administered via SQ injection and a daily steroid administered orally that is approved for twelve weeks of therapy. The moderate-severe AD patient market is primarily being served by SQ administered monoclonal antibodies. A minority proportion of patients with atopic dermatitis elect to take JAK inhibitors as an oral alternative, in part due to concerns around the black box warning.
About ‘1104
‘1104 is a first-in-class peptide that is involved in restoring immune homeostasis, uniquely impacting both the regulatory and effector arms of the immune system. Revolo has recently advanced ‘1104 through a Phase 2a trial in eosinophilic esophagitis (EoE) and a clinical mapping study in patients with allergic rhinitis, while exploring its potential for other allergic diseases. Revolo is planning to advance a commercially differentiated orally administered (sublingual) form of ‘1104 into clinical studies for EoE and atopic dermatitis, as well as other type 2 allergic diseases.
About Revolo Biotherapeutics
Revolo is developing therapies that work upstream in the immune cascade for the treatment of allergic and autoimmune diseases, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1104 and ‘1805, a peptide and a protein respectively, restore immune homeostasis to prevent the chronic pro-inflammatory immune response that results in allergic or autoimmune disease. The disease-agnostic mechanism of action of Revolo Biotherapeutic’s assets provides a potential platform for the development of treatments for multiple allergic and autoimmune diseases.
For further information, please visit www.revolobio.com.
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