This is complex, but I wouldn’t really put Bisantrene into the preclinical stage for FTO - it is really more Phase I. The reason why is we know a huge amount about how Bisantrene behaves in humans that you just don’t know with a typical preclinical drug especially around safety, metabolism and pharmacology. Phase I is all about safety and dosing, what we lack is human data (for FTO) around efficacy (Phase II/III data)
From a FTO risk perspective I would consider Bisantrene to have the same risk profile of a typical drug that had passed Phase I (i.e. safe), but without any efficacy data.
Pillar 1 - FTO (new thread), page-430
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