Antisense Therapeutics Limited announced that it has received regulatory authority approval from the Turkish Medicines and Medical Device Agency (TMMDA) to conduct its double-blind, placebo controlled Phase IIb trial of ATL1102 in non-ambulant boys with Duchenne muscular dystrophy (DMD). As previously advised, the Company had submitted a Clinical Trial Application (CTA) for approval to conduct the Phase IIb trial in UK, Bulgaria and Turkey. This first trial approval by a regulatory authority is an important milestone for the Company in affirming the quality and acceptability of the Phase IIb trial design and critically, in providing the `green light' for trial initiation at expected high patient enrolling sites.

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 ATL1102 once weekly (blinded phase), participants will continue into a further six-month open label treatment period. Trial approvals in Bulgaria, the UK and Australia are expected to come through in a staggered manner depending on the respective regulatory agencies' evaluation process and timelines.

The Company will make further announcements as and when material progress updates emerge. As per previous guidance, reporting of the results from the blinded phase of the trial is anticipated in First half of 2024.