As of the most recent check, Alterity Therapeutics Limited’s (NASDAQ: ATHE) stock was up 36.09%, trading at $2.17 on the US stock charts. The news of a significant success in its ATH434-201 Phase 2 clinical study triggered the spike in ATHE shares. This milestone marks the completion of clinical evaluations for the last enrolled patient, propelling the company closer to revealing its topline results, anticipated in late January or early February 2025.
Trial Goals and Overview
To evaluate the safety and efficacy of ATH434 in patients with early-stage multiple system atrophy (MSA), a rare neurological condition, a randomized, double-blind, placebo-controlled study known as the ATH434-201 Phase 2 trial was developed. Alterity was aiming assessing the impact of the drug on neuroimaging and protein biomarkers, such as aggregating α-synuclein and brain iron, which are significant in MSA pathogenesis.
Additionally, clinical endpoints, safety, pharmacokinetics, and motor activities monitored via wearable sensors form part of the comprehensive evaluation. 77 volunteers were recruited for the experiment and randomly randomized to receive either a placebo or one of two dosage levels of ATH434. Every participant received therapy for a full year, which yielded useful information for the planning of a conclusive Phase 3 study.
Advancing Toward Data Analysis
With the final patient visit completed, Alterity Therapeutics is now focused on the critical process of cleaning and locking the database. This step will enable the reporting of topline data early next year, a milestone eagerly awaited by stakeholders in the MSA community. The trial’s completion reflects the collaborative efforts of clinical sites, physicians, and patients worldwide, highlighting the strong interest in finding a potential treatment for this debilitating disease.
Implications for Future Research
The ATH434-201 trial represents a significant stride in Alterity’s mission to address MSA. By targeting biomarkers associated with disease progression, the study aims to provide robust evidence for ATH434’s therapeutic potential. The findings from this trial will lay the foundation for designing a Phase 3 study, bringing the company closer to a potential breakthrough in the treatment of MSA.