Alterity Therapeutics Presents Promising Impact of ATH434 on Orthostatic Hypotension and Disease Progression in MSA at the 36th International Symposium on the Autonomic Nervous System

Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) said the USPTO granted a new U.S. composition of matter patent for ATH434, covering a crystalline mesylate form and treatment methods. The patent extends protection to at least 2045 and supports Phase 3 MSA plans by year-end 2026, with potential expansion to Parkinson’s disease.

Alterity Therapeutics (ATHE) discussed at Canaccord Genuity’s Growth Conference its lead drug ATH434 for multiple system atrophy. The company said Phase II showed 34% to 46% slower decline versus placebo on the MSA Rating Scale, and FDA alignment on Phase III design, with a planned 200-patient, 12-month trial using 50 mg twice daily. It modeled peak sales of $2.4B.

Alterity Therapeutics said FDA end-of-Phase 2 meeting minutes for ATH434 in multiple system atrophy confirm a registrational plan: one pivotal Phase 3 trial plus confirmatory evidence could support approval. The Phase 3 is expected to start by year-end 2026, enrolling ~200 patients randomized 1:1 to ATH434 50 mg vs placebo twice daily for 12 months.

Alterity Therapeutics said FDA end-of-Phase 2 meeting minutes for ATH434 in multiple system atrophy confirm a registrational plan: one pivotal Phase 3 trial plus confirmatory evidence could support approval. The Phase 3 is expected to enroll ~200 patients, randomized 1:1 to ATH434 50 mg or placebo twice daily for 12 months, with initiation by year-end 2026.

Alterity Therapeutics said the FDA agreed on key elements of the Phase 3 trial design for ATH434, including the study population and dosing regimen, after Phase 2 results showed 48% slowing of disease progression vs placebo. The company expects Phase 3 activities to start by year-end 2026. Alterity also cited April Phase 2 analyses and positive FDA Type C feedback on CMC.

BioNTech (NASDAQ:BNTX) halted a mid-stage trial of its mRNA cancer vaccine, autogene cevumeran, due to an overall survival imbalance. The decision raises concerns about its mRNA strategy in colorectal cancer and other 'cold' tumors. BioNTech plans to continue other trials, including one for pancreatic cancer and BNT113 for head and neck cancer. The company also focuses on diversifying its oncology pipeline. According to Reuters, the news caused a 7.5% drop in BioNTech's US-listed shares.