OPERATING REVIEW CONTINUED Preparation for Phase 3 In order to expedite the overall development plan, in parallel with conducting the Phase 2 trials Neuren has been executing the additional development work required to be ready for Phase 3 development. Non-clinical toxicity studies to support longer clinical trials and commercial use of the product have been completed. Optimisation and scale-up of the drug product and drug substance manufacturing arrangements are well advanced, with manufacturing of supplies for Phase 3 trials scheduled in 2024. Neuren plans to discuss proposals for Phase 3 development in Phelan-McDermid syndrome with the FDA during 2024. Mean CGI-I score of 2.4 with 16 out of 18 children showing improvement Mean CIC score of 2.7 with 15 out of 18 children showing improvement Significant improvement assessed by both clinicians a Clinician and caregiver global efficacy measures showed a level of imp considered clinically meaningful Mean CGI-I score of 2.4 with 16 out of 18 children showing improvement Mean CIC score of 2.7 with showing impro 1 - Very Much Improved 2- Much Improved 3 - Minimally Improved 4 - No Change 5 - Minimally Worse 6 - Much Worse 7 - Very Much Worse Score at Week 13 EOT (Visit 16) Waterfall Plot of CGI-I Overall Score ITT Population Individual Subjects All subjects (n=18) ssed by both clinicians and caregivers 31 measures showed a level of improvement typically ed clinically meaningful n Mean CIC score of 2.7 with 15 out of 18 children showing improvement Score at Week 13 EOT (Visit 16) Waterfall Plot of Caregiver Impressions of Change Score ITT Population Individual Subjects All subjects (n=18) 1 - Very Much Improved 2- Much Improved 3 - Improved 4 - Unchanged 5 - Worse 6 - Much Worse 7 - Very Much Worse Neuren Pharmaceuticals Limited Annual Report 2023 11
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