Eupraxia Pharmaceuticals Reports EP-104GI’s P-Ib/2a (RESOLVE) Study Expansion to Treat Eosinophilic Esophagitis (EoE)
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- Based on positive data from RESOLVE study, Australian Health Authority and Health Canada agreed on expansion of P-Ib/IIa (RESOLVE) study to assess safety & efficacy of EP-104GI to treat EoE; additional data will be disclosed periodically. Registrational trial initiation is anticipated in 2025
- Study continues to evaluate safety & efficacy of EP-104GI at higher doses (4 mg & 6 mg per injection site, and an option of ~20 injections for dose escalation) in arms 1 to 3, participants will increase to 27–33 with an additional enrolment of 10-24 in 1 or 2 dose confirmation arms (at doses identified during dose escalation stage)
- Also evaluate longer duration of EP-104GI’s effect in those who will receive >40 mg (total dose), extension of follow-up period from 24wks. to 52wks. with addition of esophagogastroduodenoscopy procedure with esophageal biopsies at 36wks; new clinical sites will be added
Ref: Eupraxia Pharmaceuticals | Image: Eupraxia Pharmaceuticals
Related News:- The US FDA Approves Takeda’s Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis (EoE)
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