Neuren Commences Dosing in Landmark Phase 3 Trial for Phelan-McDermid Syndrome

Neuren Pharmaceuticals Limited (ASX: NEU) has initiated treatment in its global Phase 3 Koala clinical trial for Phelan-McDermid syndrome, marking a major milestone as the first late-stage study ever conducted in this condition. The initial participant has now progressed through screening and entered the treatment phase, which involves twice-daily dosing over 13 weeks. The trial is designed to assess the safety and efficacy of NNZ-2591 in approximately 160 children aged 3 to 12 years and is supported by multiple regulatory designations in the United States that aim to accelerate development for rare paediatric conditions. Trial activity is expected to increase over the coming months as additional sites activate across the US and more participants commence screening and dosing, reflecting strong engagement from the patient community.

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