Several posters have suggested that Fragile-X and TBI be revisited.
I assume Fragile-X is part of the previous NEU Trofinetide USA deal.
I wasn't around when NEU ran their TBI trial. I assume this is still NEU and not involving Acadia at this point in time.
If NNZ-2591 is supposed to be a more advanced and more effective version of Trofinetide, I think there are some important questions for NEU & Acadia to consider before they undertake new trials for Syndrome-X, TBI and other potential INDs:
1. It seems like NNZ-2591 potentially could be used for Rett but you wouldn't want to go back and prove given the expense and long timeframe. Can NNZ-2591 address all of what Trofinetide does or potentially can do with the same or better safety profile? ie. Does NNZ-2591 supersede Trofinetide or are there valid differences and value in keeping both drugs for trials beyond Rett worldwide?
2. Should Acadia now do a deal or revise their current deal for Trofinetide with NEU, to use NNZ-2591 instead of Trofinetide or perhaps both for a Syndrome-X trial in the USA?
3. Should NEU redo the TBI using NNZ-2591 instead of Trofinetide or should they trial both with optimised dosage if that was one of the issues why the previous trial was unsuccessful?
4. If NNZ-2591 is a derivative of Trofinetide, is there a FDA fast path trial and approval pathway NEU & Acadia can follow to shortcut trial costs and timeframes?
Looking forward to watching and listening to Jon Pilcher being interviewed this week and hearing about NEU's next steps.
GLTA on Monday and beyond. I wouldn't like to be one of those who have shorted NEU in recent times.
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