Positive interim data from ATH434-202 Phase 2 clinical trial

Alterity Therapeutics (ASX: $ATH) has announced positive interim data from the ATH434-202 open-label Phase 2 clinical trial in patients with multiple system atrophy (MSA). The trial showed that 43% of participants experienced improvement on the UMSARS Activities of Daily Living Scale after 6 months of treatment with ATH434. Additionally, 29% of participants had stable or improved neurological symptoms, and objective biomarkers demonstrated improvement consistent with clinical findings. The trial also found that ATH434 was well-tolerated with no safety signals detected.

Executive commentary on interim data

David Stamler, Chief Executive Officer of Alterity, expressed his encouragement at the positive interim data, highlighting the unexpected favorable clinical and biomarker outcomes in some patients. He also emphasized the potential of ATH434 to modify the course of the devastating condition of MSA. Dr. Stamler further noted the reinforcement of confidence in the ATH434 development program and the significance of enrolling earlier stage MSA patients in the randomized, double-blind clinical trial ATH434-201. Dr. Daniel Classen, Professor of Neurology at Vanderbilt University Medical Center and principal investigator for the ATH434-202 Phase 2 study, expressed his gratification at the improved patient selection and optimized biomarker endpoints in the Alterity Phase 2 trials, indicating increased confidence in the chosen biomarker and clinical endpoints to evaluate the potential effect of ATH434 in individuals with MSA.

Summary of ATH434-202 interim results and outlook

The interim data from the ATH434-202 Phase 2 clinical trial demonstrated promising outcomes, with a significant proportion of participants showing improvement in UMSARS scores and stable or improved neurological symptoms. The biomarker assessments also indicated positive trends, with stable brain volume and reduced accumulation of iron in clinical responders. The safety profile of ATH434 was favorable, with no serious adverse events related to the study drug reported. The results reinforce confidence in the potential of ATH434 to modify the course of MSA and provide hope for individuals suffering from this rapidly progressive disease. Looking ahead, the final 12-month data from the ATH434-202 trial are expected in the first half of 2025, offering further insights into the impact of ATH434 treatment on advanced MSA patients.