QurAlis has received clinical trial authorisation (CTA) in the European Union (EU) to initiate a first-in-human, Phase I ANQUR clinical trial of QRL-201 for the treatment of amyotrophic lateral sclerosis (ALS).

Determining the tolerability and safety of multiple QRL-201 doses in patients with ALS is the primary objective of the placebo-controlled, multi-centre, double-blind, global, randomised, multiple-ascending dose study.

A total of 64 participants with ALS will be enrolled across sites in the US, the UK, Canada, and the EU.

The trial will also assess the pharmacokinetics of the therapy against a placebo in ALS patients.

It is said to be the first-ever study to evaluate a therapy that rescues STATHMIN-2 (STMN2) expression in patients with ALS.

QurAlis CEO and co-founder Kasper Roet said: “This EU Clinical Trial Authorisation marks the second regulatory clearance for QRL-201, as we execute our global strategy focused on bringing breakthrough precision medicines to patients with ALS and other neurodegenerative diseases.

“We believe QRL-201 has the potential to halt disease progression, which could transform the care and treatment of ALS.

“We are dedicated to ensuring efficient advancement of our ANQUR clinical trial so that we can fulfil our mission to make a meaningful difference in patients’ lives.”

The ANQUR trial is expected to be initiated by the fourth quarter of this year in participating EU countries, including the Netherlands, Ireland, Germany, and Belgium.

As part of the CTA clearance in Canada, QurAlis has recently dosed the first patient and has completed patient enrolment in the Cohort I portion of the ANQUR clinical trial.