Alterity Therapeutics Completes Enrolment in ATH434-201 Phase 2 Clinical Trial in Multiple System Atrophy

– ATH434-201 is a randomized, double-blind, placebo-controlled study in early-stage MSA –

– Lead clinical development program enrolled 77 participants globally –

MELBOURNE, Australia and SAN FRANCISCO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced it has successfully completed enrolment in its ATH434-201 Phase 2 clinical trial. ATH434-201 is a randomized, double-blind, placebo-controlled study in patients with early-stage multiple system atrophy (MSA) conducted across the U.S., Europe, Australia and New Zealand.

“Completing enrolment in our ATH434-201 clinical trial in MSA is a significant milestone for Alterity as we look to bring a new oral therapy to people living with this devastating disease,” said David Stamler, M.D., Chief Executive Officer of Alterity. “Due to the great clinical need and physician interest in our novel approach to address the underlying pathology of MSA, we exceeded our enrolment target. With our trial now fully enroled, study treatment will conclude in the fourth quarter of 2024 and the results from the trial will clarify the path forward for potential approval of ATH434.”

“We sincerely thank the clinical trial participants, investigators, and all study staff for their dedication and ongoing support of the study as we pursue the common goal of improving treatment of MSA,” concluded Dr. Stamler.

About ATH434-201 Phase 2 Clinical Trial

The ATH434-201 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will evaluate the effect of ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement and clinical endpoints to demonstrate efficacy, in addition to assessments of safety and pharmacokinetics. Selected biomarkers, such as brain iron and aggregating α-synuclein, are important contributors to MSA pathology and are therefore appropriate targets to demonstrate drug activity. Wearable sensors have also been employed to evaluate motor activities that are important to patients with MSA. The study enrolled 77 adults who were randomly assigned to receive one of two dose levels of ATH434 or placebo. Participants will receive treatment for 12 months which will provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study. Additional information on the Phase 2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091.