Company: ATHE
Filing Date: 2025-08-29
Form Type: 20-F
Source: 0001213900-25-082027
Chunk: 50

Company: ALTERITY THERAPEUTICS LTD
Filing Date: 2025-08-29
Form: 20-F
Item: Item 4
Chunk 50
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 a 30% relative treatment effect at the 75 mg dose at 52 weeks.

Additional efficacy assessments showed improvement consistent with the UMSARS I findings. The Clinical Global Impression of Severity Scale demonstrated improvement compared to placebo at both dose levels, with difference at 50 mg achieving nominal statistical significance (p=0.0088). On the Orthostatic Hypotension Symptom Assessment (a patient reported outcome), on average, placebo patients worsened by approximately 6 points over 52 weeks whereas both ATH434 treatment groups improved over the same period (p=0.08 at 50 mg, p=0.14 at 75 mg). Baseline differences in disease severity likely explain the different responses in 50 mg and 75 mg treatment groups.

Increased activity in the outpatient setting was observed at both dose levels as compared to placebo as measured by the wearable sensors utilized in the trial, with clinically meaningful improvements in step count, bouts of walking, total walking time, and total standing time. ATH434 was well tolerated with similar adverse event rates compared to placebo and no serious or severe adverse events attributed to ATH434. Regarding neuroimaging in 61 participants, ATH434 demonstrated target engagement by stabilizing or reducing iron accumulation at both dose levels compared to placebo in MSA affected brain regions. In addition, ATH434 demonstrated trends in reducing brain atrophy at both dose levels compared to placebo. Overall, the study results support continued advancement of ATH434 for the treatment of MSA.

Multiple presentations have been delivered on the ATH434-201 trial:

●   May 2025 – International MSA Congress, Title: “ATH434 Slowed Disease Progression in a Phase 2 Study in Multiple System
                                                           Atrophy”                                                       
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●   April 2025– American Academy of Neurology (AAN), Title: “Topline Data from a Randomized, Double Blind, Placebo Controlled
                                       Phase 2 Study of ATH434 in Multiple System Atrophy”                                   
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●   April 2025– American Academy of Neurology (AAN), Title: Association Between Wearable Sensor Data and Clinical Scores in Individuals
                                                 with Early-stage Multiple System Atrophy”                                             
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●   April 2025 – MSA Research Symposium, Title: “A Randomized, Double Blind, Placebo Controlled Study of ATH434 in MSA”
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●   September 2024 - International Congress of Parkinson’s Disease and Movement Disorders® (MDS), Title