Revolo Biotherapeutics says it is accelerating plans to bring a sublingual (under-the-tongue) version of its peptide drug ‘1104 into clinical trials, following positive preclinical results in atopic dermatitis models.

The formulation achieved rapid and extensive systemic exposure and showed impact across several disease measures, including visible reductions in skin inflammation and biological markers of allergic inflammation. According to the company, these results are consistent with earlier data from both subcutaneous and intravenous versions of ‘1104 in models of allergic diseases.

The sublingual version is expected to enter human trials in 2026 and would represent a shift from injectable administration towards a more patient-friendly option, particularly in conditions like eosinophilic esophagitis (EoE) and atopic dermatitis (AD), where current therapies include injectables and short-term oral steroids.

“A sublingual therapy would provide a convenient alternative to more invasive treatment modalities,” said Kari Brown, chief medical officer at Revolo. “Conversations with physicians have highlighted that a sublingual option would better align with patient preferences.”

The company claims ‘1104 is differentiated by its upstream mechanism of action, which aims to restore immune balance by targeting both the regulatory and effector arms of the immune system. It also points to a favourable safety profile demonstrated in multiple Phase 2 trials with the intravenous formulation.

“As far as we know, there is no other candidate in advanced clinical development that is orally administered and targets the immune cascade upstream,” said Woody Bryan, president and CEO of Revolo.

“We believe this opens the door to a potentially transformational product profile.”

Professor Evan Dellon, a gastroenterologist and principal investigator on earlier EoE studies of ‘1104, said that an oral version of the drug could present an innovative approach to first-line therapy. “Given that blood levels of the oral formulation approach those of the IV version, the potential to dose ‘1104 in a convenient, patient-friendly delivery system is extremely promising,” he added.

Currently, only two products are approved in the US for EoE: a subcutaneously administered monoclonal antibody given weekly and a daily oral steroid approved for 12-week courses. For moderate-to-severe AD, monoclonal antibodies remain the mainstay of treatment, although some patients opt for JAK inhibitors as an oral alternative, despite concerns around black box warnings.

Revolo’s peptide candidate ‘1104 has previously completed a Phase 2a trial in EoE and has been tested in a clinical mapping study for allergic rhinitis. The company says it plans to explore the sublingual version across a range of type 2 allergic diseases.