Alterity Therapeutics: ATH434-202 Phase 2 Clinical Trial Shows Positive Data In MSA

(RTTNews) - Alterity Therapeutics Ltd. (ATHE) announced Wednesday positive interim data from the ATH434-202 open-label Phase 2 clinical trial in patients with multiple system atrophy or MSA.

MSA is a rare, neurodegenerative disease characterized by failure of the autonomic nervous system and impaired movement.

Alterity's lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce a-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain.

In the trial, a total of 10 participants have been enrolled. The participants in the trial were diagnosed with MSA using a multimodal approach comprising clinical, neuroimaging, fluid biomarkers, and treated with oral ATH434 75 mg twice daily.

The interim analysis included clinical and biomarker data on 7 participants treated with ATH434 for 6 months and neuroimaging data on 3 participants who were treated for 12 months.

The interim data, from the 7 patients who have completed six months of treatment with ATH434, shows that it was well-tolerated with no safety signals detected.

The biotechnology company focused on neurodegenerative diseases noted that 43% of participants, after 6 months of treatment, showed improvement on the UMSARS Activities of Daily Living Scale, , indicating reduced disability on activities of daily living.

Over the same period, 29% of participants had stable or improved neurological symptoms as assessed by both the treating physician and the patient.

In general, ATH434 was well tolerated by study participants and most adverse events were mild to moderate in severity.

Clinical, biomarker and safety assessments were conducted during the study. While the data are preliminary, the company said it sees a positive trend with the current participant patient outcomes.

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