Alterity gets FDA meeting minutes backing Phase 3 path for ATH434 in MSA

Alterity Therapeutics announced on 7 July 2026 that it received official FDA minutes from its End-of-Phase 2 meeting for ATH434 in Multiple System Atrophy (MSA). The company said the minutes confirm the previously announced End-of-Phase 2 outcomes and give more detail on the planned Phase 3 protocol.¹

The minutes affirm the main components of the registrational Phase 3 program the company had announced on 9 June 2026, as well as a route toward a possible New Drug Application filing.¹

According to the release, the FDA agreed with Alterity's proposed Phase 3 design, covering the patient population, dosing regimen, and efficacy endpoints.¹ The two sides aligned on using the 11-item UMSARS Part I scale, which measures daily living activities affected by MSA, as the primary endpoint.¹ Key secondary endpoints were also agreed upon, including the Swallowing Disturbance Questionnaire, the Orthostatic Hypotension Symptom Assessment, and the Clinical Global Impression of Severity.¹

The Phase 3 trial is expected to enroll about 200 patients, randomized 1:1 to receive either 50 mg of ATH434 or a matching placebo twice daily for 12 months.¹

The FDA indicated that a single pivotal trial combined with confirmatory evidence could be sufficient to support approval of ATH434 for MSA.¹ Alterity said it expects data from its ATH434-201 Phase 2 trial to serve as that confirmatory evidence.¹ The FDA also said the anticipated size of the safety database at the end of Phase 3 was reasonable.¹

Alterity plans to offer an open label extension for participants completing the Phase 3 trial, both to continue treatment and to build out the safety database.¹

CEO David Stamler said the FDA's willingness to accept a single pivotal trial with confirmatory evidence provides a clear path for ATH434 in MSA, and that the company is finalizing the protocol while remaining on track to begin Phase 3 activities by year-end 2026.¹