Alterity Therapeutics Says US FDA Meeting Minutes Confirm Key Elements of Phase 3 MSA Treatment Candidate Program; Shares Fall 4%

Alterity Therapeutics (ASX:ATH) said the official meeting minutes from its end-of phase-2 meeting for its ATH434 treatment candidate in multiple system atrophy (MSA) from the US Food and Drug Administration (FDA) confirmed the key elements of the registrational phase 3 program and the path toward a potential new drug application filing, according to a Tuesday Australian bourse filing. The US FDA agreed with the proposed phase 3 trial design, including the study population, treatment regimen, and efficacy endpoints, per the filing. The study is expected to enroll around 200 participants who will receive 50 milligrams doses of ATH434 or matching placebo twice daily for 12 months. The FDA indicated that a single pivotal trial plus confirmatory evidence could provide the necessary data to support an approval of ATH434 for the treatment of MSA, the company said. Pivotal phase 3 trial activities are on track to start by the end of the year. Alterity Therapeutics' shares fell 4% in recent trading on Tuesday.