"I mention these different clinical applications to highlight the potential of ATL1102. Despite our initial
focus in non-ambulant boys using ATL1102 as monotherapy, the Phase IIb study has the potential to
deliver an important contribution to the understanding and treatment of DMD. The study is designed
to demonstrate (i) a difference in PUL2.0 against placebo at 6 months; (ii) stabilisation or improvement
of clinical effect after 12 months of treatment; and (iii) the clinical impact of delayed treatment between
the placebo and active treatment groups. Clinically significant results, from a Phase IIb study, would
represent a major advancement in the treatment of DMD. It is our intent to share the study results
with the FDA as precedent exists in the space of rare neuromuscular disease for positive results from
a well-designed and executed study serving as the basis for an accelerated approval. With the FDA
IND 9-month monkey toxicology study underway (12 out of 40 doses successfully administered to
Page 3 of 4
date), we are likely permitted to submit either a DMD clinical study protocol or the Phase IIb study
results to initiate lifting of the partial hold on the IND. This latter activity, which opens the USA market,
is planned for 2H-2024.
Completing the Phase IIb clinical trial and moving toward an approval for DMD in both the EU and US
regulatory jurisdictions are key strategic imperatives and we are laser focused on achieving these
goals. I appreciate that since announcing our amended strategy in late 2022 it may not be obvious
what has been achieved. Much headway has been made since an agreement was signed with Parexel
in October 2022 for them to be the clinical research organisation running the trial on our behalf. Parexel
advised that study set-up activities would take at least six months if no unforeseen delays eventuated. "
Which is why I like this part of the shareholder newsletter sent in June this year.
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- Ann: Antisense Therapeutics Corporate Presentation
Ann: Antisense Therapeutics Corporate Presentation, page-60
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