Alterity Therapeutics Gains Positive FDA Feedback for ATH434 Phase 3 MSA Trial
Alterity Therapeutics received written FDA feedback endorsing its clinical pharmacology and nonclinical development plans for the ATH434 Phase 3 trial in Multiple System Atrophy. The company will seek FDA agreement on CMC and trial design ahead of a mid-2026 End-of-Phase 2 meeting.
1. FDA Meeting Outcome
Alterity held a Type C meeting with the FDA to discuss the ATH434 Phase 3 program in Multiple System Atrophy. The agency provided written feedback supporting the company’s clinical pharmacology and nonclinical development plans.
2. Phase 3 Development Plans
Alterity plans to finalize Chemistry, Manufacturing, and Controls (CMC) protocols and refine its pivotal trial design based on FDA input. Alignment in these areas is critical for initiating the Phase 3 trial as planned.
3. Timeline and Next Steps
The company targets a mid-2026 End-of-Phase 2 meeting with the FDA to confirm readiness for Phase 3 initiation. Subsequent discussions will focus on final protocol and regulatory submissions.
4. ATH434 and MSA Background
ATH434 demonstrated clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 trial in MSA patients. The asset’s favorable safety profile and open-label Phase 2 data support its advancement into pivotal studies.