Revolo Biotherapeutics plans to initiate a Phase IIb clinical trial investigating immune-resetting peptide ‘1104 (IRL-201104) in eosinophilic esophagitis (EoE) following an orphan drug designation from the US Food and Drug Administration (FDA).
Revolo initially submitted a request before the initiation of the Phase IIa trial but then sent a revised request following the results of an additional Phase II study. The biotech is headquartered in both New Orleans, US, and London, and is focused on targeting the immune system for treating autoimmune and allergic conditions.
Positive results from the Phase IIa RVLO 121-04 trial (NCT05084963), demonstrated efficacy, safety, and tolerability of ‘1104 in adults with active EoE. Results included improvements in patient-reported dysphagia symptoms, reductions in eosinophils and other immune cells in the oesophageal tissue and increase in regulatory immune cells.
Revolo reported interim data in April 2023, where the trial met its primary endpoint. The company initially failed to disclose whether or not ‘1104 had met its secondary endpoint—dysphagia median symptom scores (DSQ)—the symptom scale that earned Sanofi and Regeneron’s Dupixent approval. However, Revolo confirmed in July with additional data that this all-important endpoint had been met.
If approved, Revolo’s candidate would be on track to challenge Sanofi and Regeneron’s Dupixent (dupilumab), the only FDA-approved drug for EoE.
Dupixent, which is approved for treating four conditions, including EoE, generated $8.29bn in 2022, as per Sanofi’s 2022 full year report. According to an analyst consensus forecast on GlobalData’s Pharma Intelligence Center, Dupixent is forecast to generate to $20.4bn by 2029.
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‘1104 is a synthetic peptide that reduces neutrophil recruitment into the lung, decreasing inflammation. The Phase IIb trial will evaluate increased dose levels of ‘1104 and a longer duration of therapy.
EoE is a chronic allergic condition that causes inflammation in the oesophagus due to reactions to certain foods or allergens. It leads to symptoms like difficulty swallowing and chest pain, with dietary changes and medications used to manage inflammation.
Revolo also investigated the drug candidate in another Phase IIa trial (NCT05098522) for patients with allergen sensitivity, reporting positive topline data in October 2023.
In the announcement accompanying the ODD, principal investigator for the Phase IIa clinical trial Evan Dellon said: “1104 is a promising EoE therapeutic with a novel mechanism of action. Based on the proof-of-concept data from the Phase 2a study, I am eager to see this molecule move forward into the next stage of development.”