ProJenX’s PRO-101 trial is a three-part Phase I clinical trial with Parts 1a and 1b having already been completed. Credit: Shutterstock / Atthapon Raksthaput.

US-based clinical-stage biotech ProJenX has been given authorisation by Health Canada to launch the final part of its Phase I clinical trial evaluating prosetin in patients living with amyotrophic lateral sclerosis (ALS).

The clinical trial application (CTA) authorisation allows ProJenX to initiate Part 1c of the PRO-101 trial. It is a global, hybrid trial designed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of prosetin in healthy volunteers and participants with ALS.

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PRO-101 (NCT05279755) is a three-part Phase I clinical trial with Parts 1a and 1b having already been completed.

ProJenX CEO Erin Fleming said: “Following Health Canada’s CTA authorisation, we will be able for the first time to evaluate prosetin in people living with ALS. We are encouraged by the safety and tolerability profile that has emerged from completed healthy volunteer studies of prosetin, and we are laser-focused on initiating ALS patient enrolment in Canada as quickly as possible.”

Research published by GlobalData found that there are as many as 39 drugs currently in development for the treatment of ALS, the second most frequent indication for drugs neuroimmunology therapeutics pipeline, lagging behind only Alzheimer’s disease with 75 drugs in the pipeline. Additionally, the report found that global sales of neuroimmunology drugs reached as high as $20.1bn in 2020, with that figure expected to rise to $26.6bn by 2025.

GlobalData is the parent company of Clinical Trials Arena.

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Prosetin is a selective, oral, brain-penetrant, MAP4K inhibitor. It was developed in conjunction with the company’s co-founders at Columbia University after it was discovered that MAP4K had the ability to confer motor neuron protection across multiple patients’ stem cell-derived models of ALS.

PRO-101 trial study investigator Angela Genge said: “Despite scientific advances, ALS remains a fatal, devastating neurodegenerative disease that demands more meaningful treatment options.”

It comes as the US National Institute of Health (NIH) has previously announced additional funding for three other clinical trials investigating therapeutic treatments for ALS following the US Government’s 2021 implementation of the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS).