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A Phase 3 Registrational Study of EDP1815 for Psoriasis

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Trial Profile

A Phase 3 Registrational Study of EDP1815 for Psoriasis

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 08 Feb 2023

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At a glance

  • Drugs EDP-1815 (Primary)
  • Indications Psoriasis
  • Focus Registrational; Therapeutic Use
  • Sponsors Evelo Biosciences

Most Recent Events

  • 01 Feb 2023 According to an Evelo Biosciences media release, clear path to registration trials for EDP1815 in psoriasis based on recently completed interactions with FDA, EMA and MHRA. The Company is incorporating the comments received into phase 3 study designs.
  • 14 Nov 2022 According to an Evelo Biosciences media release, initial written feedback was received from the FDA. A meeting with the FDA has been requested to discuss the Company'ss registration trial plan.
  • 14 Nov 2022 According to an Evelo Biosciences media release, the Company has completed scientific advice meetings and received feedback from the EMA and MHRA on this study design. Both agencies provided supportive feedback regarding critical components of the chemistry, manufacturing and control (CMC) for the proposed registration trials.

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