I think the Fragile X references in the annual report are also of major interest. NEU’s deal with ACADIA rests heavily on the success of Fragile X - with the AUD640 million in potential milestone payments being contingent on the success of both Retts and Fragile X.
Clearly ACADIA also knows that where the real value of Trofenetide lays (ACADIA has stated the peak annual sales potential for Rett syndrome alone as being more than US$500 million and 4 times as many patients with Fragile X as with Rett syndrome), so would be working hard to expedite further trials and finalising Phase 3 for Fragile X.
ACADIA said itself in its 9 April presentation that it sees Trofinetide as being one of their key areas of expansion in the next 12 months – this isn’t just limited to Retts.
So I think there could be some announcements in relation to Fragile X this year, including with the finalisation of Phase 2/commencement of Phase 3. NEU has now completed FDA’s division of psychiatry’s additional requirements, confirmed in the annual report
(page 8 of the annual report)The FDA Division of Psychiatry Products required the chronic dosing toxicity studies that have recently been completed for the Rett syndrome Phase 3 trial to be completed before a clinical trial of longer duration could be conducted in children with Fragile X syndrome.
The next Fragile X trial also requires drug supply from the commercial process being developed to supply the Rett syndrome Phase 3 trial. In the meantime, Neuren is working with ACADIA to design the most efficient development program for Fragile X.
NEU Price at posting:
$1.18 Sentiment: Hold Disclosure: Held
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