Ticonderoga, No, there have been no outward clinical manifestations associated with the histo finding at all. And in all the human clinical trials to date CX-717 (phase 1, the UK Sleep study, the three Phase 2a studies), they haven't even seen a single SAE/serious adverse event. The sister compound Org-24448 has reportedly also had excellent safety in its Schizo and Depression trials.
It's a real puzzler. I have a few theories on what might be going on, relating to excitotoxicity induced calpain mediated protein breakdown, but that's just a guess. The long term toxicological ramifications (if any) is the big question.
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