Alterity Therapeutics presents Phase 2 ATH434 MSA data

• Alterity Therapeutics reported a Phase 2 analysis showing ATH434 50 mg slowed functional decline in multiple system atrophy by about 52%.
• The adjusted analysis showed a 4.64-point difference versus placebo on the UMSARS Part I scale at Week 52.
• Alterity said it is preparing a Phase 3 trial, while noting its primary imaging endpoint was not achieved.

Alterity Therapeutics (NASDAQ:ATHE) reported additional Phase 2 analyses showing ATH434 50 mg slowed functional decline in multiple system atrophy by approximately 52% compared with placebo at Week 52.

The analysis included 61 participants and adjusted results using baseline cerebrospinal fluid neurofilament light chain levels, a biomarker associated with disease progression.

Alterity Therapeutics said the adjusted analysis showed a statistically significant difference of −4.64 points on the 11-item UMSARS Part I daily-function scale versus placebo at Week 52, with a p-value of 0.032.

The difference exceeded the 1.5-point minimal clinically important difference threshold, while the company said the statistical model was added after the trial to align with imaging analyses.

Alterity said the updated analysis supports continued development of ATH434 and preparation for a Phase 3 trial.

However, the company’s primary imaging endpoint was not met and the 75 mg dose did not show statistically significant functional improvement at Week 26 or Week 52.

The previously reported clinical analysis showed a 46% slowing of functional decline, but Alterity noted that the populations and statistical models used in the analyses were different.

Safety results showed adverse event rates were similar between ATH434 and placebo groups, with no serious adverse events attributed to ATH434 during the study.