Phase IIb/III trialThe Phase IIb/III clinical trial is a...

Phase IIb/III trial
The Phase IIb/III clinical trial is a multicentre, randomised, double-blind, placebo-controlled study to determine the efficacy, safety, and pharmacokinetic profile of ATL1102 (25 mg and 50 mg) administered once weekly by subcutaneous injection for 52 weeks in non-ambulatory participants with DMD, to be conducted as a potentially pivotal (approvable) trial with a follow-on open label extension trial. Participants will be randomised to either 25 mg ATL1102, 50 mg ATL1102 or placebo in a 1:1:1 ratio with stratification by corticosteroid use. Up to 114 participants are to be enrolled (38 per treatment arm) with 108 participants expected to complete the trial. Additional trial details and timelines are outlined in the investor presentation lodged today with the ASX.

As previously announced, ANP has appointed globally renowned Clinical Research Organisation (CRO)
Parexel to conduct and manage the Phase IIb/III European trial. Parexel is currently finalising site
evaluations to select the sites (>30) in approximately nine European countries. Patient recruitment
into the Phase IIb/III European trial will begin once requisite clinical trial application approvals are
received for each jurisdiction. Preparations of the clinical trial applications for submission to the national
competent authorities are progressing as per the timelines noted in the investor presentation.

Professor Thomas Voit MD (Director of NIHR GOSH UCL Biomedical Research Centre, UK) will be the Coordinating Principal Investigator of the trial. Dr Voit said of the PDCO outcome and the Company’s clinical plans for ATL1102 in DMD


All those magic words!! Well Done!!