Biopharmaceutical company Revolo Biotherapeutics has announced an accelerated development timeline for an orally administered version of its peptide drug candidate, ‘1104, targeting allergic diseases.
The sublingual formulation is expected to enter clinical trials in 2026, following the release of encouraging new preclinical data and strong results from earlier Phase II trials with the intravenous (IV) version.
Allergic diseases such as atopic dermatitis (AD) and eosinophilic esophagitis (EoE) are on the rise globally, with up to 4 billion people projected to be affected by 2050. Revolo’s ‘1104 seeks to address these conditions with a novel therapeutic approach: restoring immune homeostasis instead of merely suppressing inflammation after it has occurred.
Promising Preclinical And Phase II Data
Recent preclinical studies in atopic dermatitis models have shown that sublingual ‘1104 achieves extensive systemic exposure and positive effects across multiple clinical indicators, including reductions in skin inflammation and key immune and inflammatory markers. These effects mirror those seen with subcutaneous and IV administration in earlier models, reinforcing confidence in the drug’s efficacy via the oral route.
“A sublingual therapy would provide a patient-friendly approach for managing allergic diseases such as EoE and AD, offering a convenient alternative to more invasive treatment modalities,” said Dr. Kari Brown, Chief Medical Officer at Revolo.
She emphasized that physician feedback supports the potential for broader patient adoption with an oral option, particularly in the early stages of treatment.
The promise of oral ‘1104 is particularly striking in EoE, a condition for which treatment options are limited. Currently, only two therapies are approved in the US: a monoclonal antibody, Sanofi and Regeneron’s Dupixent (dupilumab), administered via weekly injection, and a daily oral steroid approved for short-term use.
Dr. Evan Dellon, a gastroenterologist and principal investigator in previous Revolo trials, noted that an oral ‘1104 formulation could be an “innovative way to approach first-line therapy” for EoE. Notably, the sublingual version achieves blood levels comparable to the IV form.
Phase IIa clinical trial (NCT05084963) data for the IV version of ‘1104 have already demonstrated notable efficacy in EoE. The randomized, placebo-controlled study enrolled 36 participants.
In the trial, patients receiving ‘1104 showed statistically significant improvements in dysphagia symptoms and reductions in esophageal eosinophil counts.
Additional findings included increased levels of regulatory T and B cells and decreased populations of inflammatory CD4+ and CD8+ T cells, with no serious adverse events or treatment discontinuations.
Revolo’s Drug Pipeline
Beyond EoE, Revolo is exploring the use of ‘1104 in atopic dermatitis and other type 2 allergic conditions. The peptide’s dual-action mechanism, impacting both regulatory and effector arms of the immune system, could offer a safer alternative to current treatments, such as injectable biologics or Janus kinases (JAK) inhibitors, such as AbbVie’s Rinvoq (upadacitinib), the latter of which carries black box warnings.
Revolo’s broader pipeline includes a second candidate, ‘1805, a protein-based therapy targeting autoimmune diseases. It is progressing toward Phase II trials in moderate-to-severe rheumatoid arthritis and another yet-to-be-disclosed autoimmune indication.
With the oral version of ‘1104 advancing rapidly toward clinical development, Revolo is positioning itself at the forefront of next-generation allergy treatments that prioritize safety, convenience, and immune system balance.
