" class="no-js "lang="en-US"> Alterity Receives Regulatory Authorization for ATH434 Clinical Trial
Friday, March 31, 2023

Alterity Therapeutics Receives Regulatory Authorization in France and Austria to Proceed with ATH434 Phase 2 Clinical Trial

Alterity Therapeutics, a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that the Company has been granted authorization to conduct its Phase 2 clinical trial for ATH434 in Multiple System Atrophy (MSA) by the Austrian Federal Office for Safety in Healthcare and the French National Agency for the Safety of Medicine and Health Products. MSA is a rare and highly debilitating Parkinsonian disorder.

“The regulatory approvals in France and Austria will allow us to expand our footprint in Europe and are another important step forward for our ATH434 development program,” said David Stamler, M.D., Chief Executive Officer, Alterity. “With the trial now open in five countries we are focused on providing access to our Phase 2 clinical trial for individuals living with MSA. We expect to open trial sites in France and Austria over the next few months.”

The 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. The selected biomarkers, including brain iron and aggregating α-synuclein, are important contributors to MSA pathology and are therefore appropriate targets to demonstrate drug activity. Wearable sensors will also be employed to evaluate motor activities that are important to patients with MSA. The study is expected to enroll approximately 60 adults 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.

  1. NEC Establishes Subsidiaries in Europe for Strengthening Global AI Drug Development Business Read more
  2. Flare Therapeutics Further Strengthens Leadership Team with Key Executive Appointments and Promotions Read more
  3. Sensorion Appoints Khalil Barrage as Interim Chairman of the Board Read more
  4. Ablaze Pharmaceuticals Plans Development of Innovative GPC3 Targeted Radiopharmaceutical Therapy for Liver Cancer in Greater China Read more
  5. Hansa Biopharma Completes Enrollment in Phase 2 Study of Imlifidase in Guillain-Barré Syndrome (GBS) Read more