Rare brain disease with no approved treatment spurs new Alterity drug push

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.

Kinder Morgan (KMI), Phillips 66 (PSX) and HF Sinclair (DINO) approved a $5 billion Western Gateway Pipeline System JV. The 1,300-mile project will move refined products to West Coast and Southwest markets, with Kinder Morgan owning 35.1%. Completion is expected in 2029; initial capacity is 230,000 bpd under 10-year take-or-pay contracts.