Were the 5-18y patients titrated to 30mg in Excellence trial? It was 5mg in US Rett adult p2 trial, then 30mg in Adult p2b/3 trial even though 20% Rett patients didn’t reach 30mg. From the AE slide, 15% of 509-patient AD p2b/3 trial patients can’t tolerate more than 10mg. However the 132-patient PDD p2 trial didn’t report any tolerability issues with neither 30 nor 50mg groups.
Is Anavex trying to confirm the optimal treatment dose is 30mg for Rett and 50mg for AD/PD with the expectation that a portion of the patients can’t tolerate that target doses, therefore titration is always required until a precision medicine is found?
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