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The main objective of this current study is to determine how safe and well-tolerated PMX-205 is in individuals diagnosed with ALS, when given as a single dose. It’s hoped the treatment will improve survival and quality of life.

Research Objectives

Status

Completed

Recruitment

Open

Patient Group

Amyotrophic Lateral Sclerosis (ALS)

Phase

1b

Study type

Industry Sponsored
Sponsors: Alsonex Pty Ltd

Lead investigator

  • A/Prof Robert Henderson

Clinical trial coordinator

  • Jacqui Langton

Technical title

An open-label, phase 1b study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of PMX205 in patients with amyotrophic lateral sclerosis.

About this research project

This research project is testing a potential new treatment for ALS, called PMX-205. PMX-205 is hoped to improve survival and quality of life. Despite the current advances in medical therapy, there is currently no known cure for Amyotrophic lateral sclerosis (ALS). The management of ALS is predominantly about providing symptomatic relief, improving quality of life, extending survival time and/or slowing disease progression.

Alsonex Pty Ltd is developing a new drug, PMX-205, that works by targeting the inflammatory pathway that is believed to contribute to the damage in nerve cells. This inflammation could be a part of the primary cause of the disease.

The main objective of this current study is to determine how safe and well-tolerated PMX-205 is in individuals diagnosed with ALS, when given as a single dose.

The study also aims to study how PMX-205 is absorbed into the bloodstream and cerebrospinal fluid (CSF, the clear fluid around the brain and spinal cord) in individuals diagnosed with ALS and the effect that PMX-205 has on participants’ immune cells (different types of white blood cells).

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