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A Phase 2b trial with COYA 302 in ALS

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Trial Profile

A Phase 2b trial with COYA 302 in ALS

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 19 May 2025

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At a glance

  • Drugs COYA-302 (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 13 May 2025 According to a Coya Therapeutics media release, Submission of additional nonclinical data to support the start of the COYA 302 Phase 2 trial in patients with ALS expected by the end of the Q2 2025.
  • 19 Nov 2024 According to a Coya Therapeutics media release, have alignment with the FDA on the data required to initiate our potentially pivotal COYA 302 Phase 2 double-blind randomized study in patients with ALS. Company is targeting the submission of the requested data package by 2Q 2025 and initiation of the clinical trial upon FDA clearance.
  • 12 Aug 2024 According to a Coya Therapeutics media release, August 9, 2024, FDA provided feedback that additional non-clinical toxicology/pharmacology data must be submitted prior to initiating this study hence company intends to discuss the recommendations with the FDA in 4Q 2024 to align on our revised non-clinical package to enable the implementation of the study.

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