RespireRx Pharmaceuticals Inc (RSPI)

[neuroinv]

Here's a slightly different perspective, given that the decision to pursue SA was based on several pieces of information.

1) Subjects in the RD trials who received CX717 did not have apnea episodes (or very few), compared to those who received placebo. Thus, to the extent to which fentanyl induced apnea episodes are in any way similar to clinical SA apnea episodes, that was taken as indicating possible amelioration of SA.
2) There is human data going back to the mid-90's wherein SA patients were given electrical stimulation of areas near the pre-Botzinger complex, where the root of the hypoglossal nerve is also located. This effectively reduced sleep apnea episodes. It's not a clinically feasible approach, but it shows stimulation of that area can reduce SA. The question remains open as to whether neurochemical stimulation of that area can produce similar results--though Point #1 suggests that it may.
3) SA is a huge and pharmacologically untreated indication. CPAP has its problems, as do surgical interventions.
4) There is enough of an anatomical rationale to make this more than an act of random desperation.

The execution of the study, in terms of timeliness, has been very disappointing. I have no way of knowing to what degree that reflects Quintiles promises unkept, or insufficient oversight. It would have been an entirely different kind of error to accept 'all comers', hoping that their variability wouldn't cause the data to be chaos. Cortex opted for the more conservative approach. We won't know whether that was a mistake until the dataset, partial or full, is eventually unblinded and reported.

NeuroInvestment