Alterity Therapeutics announced that new analysis of its lead candidate ATH434, presented at the 36th International Symposium on the Autonomic Nervous System in Florida, suggests promising impact on orthostatic hypotension (OH) and disease progression in Multiple System Atrophy (MSA).
The company said that in its Phase 2 ATH434‑201 trial, the 75 mg dose group had a 29.2 % incidence of severe OH at baseline compared with 4 % in the 50 mg arm and ~4.5 % in placebo. With OH change used as a covariate, the treatment effect on the UMSARS Part I disability scale improved from ‑2.4 to ‑2.8 points for the higher dose, raising relative effect from 30 % to roughly 35 %. Further, the company claimed ATH434 groups remained stable on the OH Symptom Assessment scale over 52 weeks while the placebo group worsened by about 6 points.
Alterity stated that ATH434 has previously shown reduction of iron accumulation in the brain and demonstrated safety in MSA patients. The company said that with these insights it is now preparing its Phase 3 protocol and upcoming regulatory interactions.
MSA is a rare, rapidly progressive neurodegenerative disease marked by autonomic nervous system failure, impaired movement, and accumulation of the protein α‑synuclein.
The company noted that the presentation will be available on its website and that ATH434 has been granted Fast Track and Orphan Drug designations.
