Antisense Therapeutics Limited announced that it has now submitted a Clinical Trial Application (CTA) in three European countries (UK, Bulgaria and Turkey) for approval to conduct its double-blind, placebo controlled Phase IIb trial of ATL1102 in non-ambulant boys with Duchenne muscular dystrophy (DMD). The CTA submission for Ethics Committee (EC) approval to initiate trial sites in Australia is scheduled for submission following the holiday period to the EC for review early in the new year. The Phase IIb study aims to enrol and randomize 45 non-ambulant boys with DMD from multiple clinical trial sites in Europe and Australia.

Following the initial six-month regimen of either placebo, 25 mg or 50 mg once weekly (blinded phase), participants will continue into a further six-month open label treatment period. The CTA submissions are a critical step in the clinical trial set-up process and represent the company's resolve to develop ATL1102 for DMD. CTA approvals are expected to come through in a staggered manner in early 2023 depending on the respective regulatory agencies' evaluation process and timelines.

As per previous guidance, reporting of the results from the blinded phase of the trial is anticipated in first half of 2024.