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Revolo advances plans to tackle eosinophilic esophagitis with orphan drug tag

2024-01-31

临床2期临床结果孤儿药上市批准免疫疗法

Eosinophilic esophagitis can be triggered by a food allergy, acid reflux, or seasonal allergies. Credit: CGN089 via Shutterstock.

Eosinophilic esophagitislans to initiate a Phasfood allergyalacid refluxstigaseasonal allergiesing peptide ‘1104 (IRL-201104) in eosinophilic esophagitis (EoE) following an orphan drug designation from the US Food and Drug Administration (FDA).

Revolo Biotherapeuticstted a request before the initiation of the Phase IIa trial but then sent a revised request IRL-201104the reosinophilic esophagitis (EoE)II study. The biotech is headquartered in both NewFood and Drug Administration (FDA)ocused on targeting the immune system for treating autoimmune and allergic conditions.

Revolove 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 di‘1104e whether or not ‘1104 EoE 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.

Revoloroved, Revolo’s candidate would be on track to challenge Sanofi and Regeneron’s Dupixent (dupilumab), the only FDA-approved drug for EoE.Sanofi Regeneron Dupixent Revolo

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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.

Defenderta is the parmotion sicknessPharmaceutical TechnoFDAy.

‘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.

Dupixent chronic allergic condition that causes inflammation in the EoEophagus due to reactions to certain Sanofior allergens. It leads to symptoms like difficulty swallowing and chest pain, with dietary changes and medicationDupixento manage inflammation.

Revolo also investigated the drug caPharmaceutical TechnologyIIa trial (NCT05098522) for patients with allergen sensitivity, reporting positive topline data in October 2023.

I1104e announcement accompanying the ODD, principal investigator for the Phase IIa clinicalinflammationDellon said: “1104 is a promising EoE therapeutic with a nove‘1104hanism 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.”

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