Health Canada has granted authorisation for the clinical trial application (CTA) of QurAlis for the Phase I ANQUR trial of its therapy, QRL-201, for amyotrophic lateral sclerosis (ALS).
The international, randomised, multicentre, double-blind, placebo-controlled, multiple-ascending dose trial will assess the safety, tolerability, and pharmacokinetics (PK) of QRL-201 compared to a placebo.
Anticipated to commence in the country early next year, the trial will enrol 64 ALS patients across sites in Canada, the US, UK, Belgium, Italy, the Netherlands, Ireland, and Germany.
Determining the safety and tolerability of varying doses of QRL-201 in ALS patients is the primary objective of the trial.
A therapeutic product candidate, QRL-201 can potentially restore STATHMIN-2 protein expression in individuals with ALS.
STATHMIN-2 is vital for neural repair and stability of axons and its expression is reduced in almost all patients with ALS.
The latest clearance from the Canadian health agency is the first part of the international regulatory approach of the company for QRL-201’s clinical development.
Additional approvals across various jurisdictions are expected soon.
QurAlis CEO and co-founder Kasper Roet said: “The authorisation of our CTA in Canada is a significant milestone for our company, representing our first program to receive clearance by a regulatory body to enter the clinic and the first ever clinical trial to evaluate a therapy that rescues STMN2 expression in ALS patients.
“We are working diligently with our investigators in Canada to begin patient enrolment and dosing as quickly as possible.
“We will continue advancing the QRL-201 clinical programme so that we can bring this potentially transformative treatment to patients rapidly and fulfil our mission to make a meaningful difference in patients’ lives.”