.
At the end of 2015 the encouraging results of the Phase 2 trial of trofinetide for potential use in treating Fragile X were released.
At the 2016 AGM our Chairman said:---
"We are encouraged by our discussions with the FDA, during which it was recognised that the broad
mechanisms of action of trofinetide make it appropriate to use a novel approach to the assessment of
Fragile X patients. We will now work with the FDA to refine and validate some of the behavioural
measures that form part of our Fragile X Syndrome Rating Scale. The Division also requested that we
provide data from the non-clinical toxicity studies that we are conducting before commencing clinical
trials in paediatric patients. Some of the studies are already underway, and all will be completed in
2017. We will also be able to provide the Division with safety and tolerability data from our paediatric
trial in Rett syndrome. Once the Division is satisfied that we have provided sufficient information, we
expect to be in a position to commence a paediatric study in Fragile X.
Since Trofinetide is owned by us shareholders and of course is desperately needed by the Fragile X sufferers, and since there was a fair amount of backroom development required to design the Phase 3 trial ... what happened?
No reports on progress since 2016 as far as I can see.
It is not good enough to hand it all over to Acadia and have them simply "bury" our previous development work.
Does anyone know anything about this Neuren sub-project?
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