(RTTNews) - Alterity Therapeutics Ltd. (ATHE) reported new analyses from its Phase 2 ATH434-201 trial showing that ATH434 50 mg slowed functional decline in patients with multiple system atrophy (MSA).

After adjusting for baseline cerebrospinal fluid neurofilament light chain (CSF NfL), ATH434 50 mg produced a 4.64-point difference versus placebo on the 11-item UMSARS Part I at Week 52 (p=0.032), representing approximately 52% slowing of functional decline.

CSF NfL is an established biomarker associated with disease progression in MSA. The analysis found that every 1,000 pg/mL increase in baseline CSF NfL was associated with approximately 0.9 points of additional UMSARS Part I worsening at Week 52.

The 75 mg dose also showed a numerical reduction in functional decline, with a 2.81-point difference versus placebo at Week 26 (p=0.072). At Week 52, the difference was not statistically significant.

The Phase 2 ATH434-201 study enrolled 77 adults with MSA who received ATH434 50 mg or 75 mg twice daily, or placebo, for 12 months. The trial evaluated functional outcomes, safety, pharmacokinetics, neuroimaging, protein biomarkers and wearable activity measures.

The study also evaluated brain iron accumulation using quantitative susceptibility mapping (QSM) MRI. While the primary endpoint of substantia nigra iron at Week 52 was not met, numerical reductions in iron were observed in the putamen and globus pallidus.

Alterity said ATH434 was well tolerated, with adverse event rates similar to placebo and no serious adverse events attributed to treatment.

The company said the findings further support ATH434's potential in MSA and provide additional evidence for using baseline CSF NfL to account for differences in disease severity in future clinical trials.

Alterity is now preparing for a Phase 3 pivotal study of ATH434 in multiple system atrophy.

ATHE has traded between $2.66 and $5.89 over the past year. Currently, ATHE is trading at $3.20, down 7.25%.