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In response to a few posters

Piton72

While I can’t remember if and when Acadia included trofinetide in Fragile-X in their advertised product pipeline, as long ago as in January last year, prior to the approval of trofinetide in Rett Syndrome and prior to the licensing of NNZ-2591 for Rett and Fragile-X, it wasn’t listed.



I question whether there ever was real intent by Acadia to develop trofinetide in Fragile-X. Since Acadia licensed trofinetide in Fragile-X almost 6 years ago, there has been nothing but silence on any planned development program.

As to whether Acadia will advance a Fragile-X program using NNZ-2591 (ACP-2591) rather than trofinetide, I think it’s a no brainer. FDA advice following Phase 2 of trofinetide in Fragile- X was that a further Phase 2 trial would need to be conducted prior to any pivotal Phase 3 trial so Acadia has little to lose, but much to potentially gain, by switching to NNZ-2591 if it decides to proceed in Fragile-X.


Innameonly

In response to your question asking if NNZ-2591 can now be considered unshackled – no, it can’t.  Just because Acadia doesn’t currently have trofinetide in development for any other indication doesn’t mean they can’t in future. NNZ-2591 can be considered unshackled in the current four indications that Neuren is pursuing (that was formalized as part of the trofinetide ROW deal) but Acadia still exercises a degree of control over any new indications proposed for NNZ-2591.

Hashan De Silva from KP Rx addressed this in his recent coverage of Neuren.

It's worth noting one significant complication in the potential acquisition of Neuren for NNZ-2591; Acadia holds the global licenses for NNZ-2591 in Rett Syndrome and Fragile X. Consequently, any acquiring entity would need to collaborate closely with Acadia through a steering committee for NNZ-2591's development. This partnership could pose a considerable obstacle to potential acquirers, greatly complicating both the developmental and commercial aspects of NNZ-2591. For instance, detailed plans for which indication will be sought for approval first, the market launch strategy, marketing approach etc. would all require close coordination with Acadia.

Clauses 6, 7 and 11 of the Joint Venture and Licence Agreement between Neuren and Acadia, executed in July last year, are particularly relevant here (available as Exhibit, ACAD Q3 2023 SEC Filing).


baldwidx

Phase 1 only has to be done once for a drug and that data can then be used in all indications. Acadia’s reference to Phase 1 being completed refers to Neuren’s Phase 1 data, to which it has access.