RespireRx Pharmaceuticals Inc (fka RSPI)

[neuroinv]

Certainly a mixed bag:
1) It looks like overall oxygenation was improved in CX1739 patients
2) It looks like three patients hit the prespecified responder endpoints for both AHI and AHT (this is assuming the two groups overlapped, which seems likely, but isn't clear from the press release--at least five hit one or the other.)
3) The long delay had left me guessing that there were some responders--and if this is replicable, providing improvement in 31% of the sleep apnea population, for whom there is no oral therapy--it would not be insignificant. Potentially millions of users.
4) The two caveats are: Can they prospectively identify the likely responders? My expectation about the delay was that this was the goal, sorting out which patients responded and why. If they figured any of that out, it is not in the PR. It might be too small a sample to draw any confident conclusions. Secondly--as Enemem had predicted, the negative effect on sleep itself, even if vigilance remains the same. Can it be moderated via lower dosing, given over time? Does the overall net effect show benefit, especially (as Athero noted) in cv functioning? That will take a larger and longer-duration trial.

Overall, the results suggest that an Ampakine can produce some benefit for a large group of SA patients. Whether this is the right dose, or the right Ampakine, and for which patients--that has yet to be established.

Does this make SA itself a partnerable indication? I'm not that optimistic, these results produce a lot more questions than most pharmas want to see when deciding on an inlicensing. More likely if combined with RD, which they can hopefully get back from Valeant. Valeant has been distracted by a $480 million Swiss generics acquisition, so RD has not been at the top of their BusDev menu.

The data are a reminder of the Ampakine effects on alertness/vigilance that speak to the ADHD indication. Certainly if Cortex were to select the #1 priority based on everything they now know, ADHD would stay at the top of the list.


NeuroInvestment