Here’s an example of a common behavior in this industry – and to be fair, in many others as well. Big deals are celebrated and press-released at the outset, but if things don’t work out, they end very quietly – as quietly as possible. Sometimes that’s not very possible at all, because a big Phase III failure (for example) is pretty hard to play down. But when something derails earlier in the process, companies generally try to move past that news as quickly as possible.
That’s what Biogen looks to be doing with amiselimod, a ligand for the sphingosine 1-phosphate receptor that they picked up from Mitsubishi/Tanabe just a year ago. Results of a Phase II trial in multiple sclerosis were, in fact, published in late August, and it looked pretty good at preventing new lesions when assessed by imaging techniques, with nothing flagged for safety. Celgene has a drug candidate (ozanimod, acquired from Receptos) targeting the same receptor, and that one is moving along as far as anyone knows.
But amiselimod was moving along fine, as far as anyone knew, until yesterday. In Biogen’s earnings report, a brief note mentioned that development of the compound had been discontinued, with no explanation at all. Something caused this program to hit the skids most thoroughly, but what? I’m sure that people will be questioning Biogen for more details, which I hope are forthcoming, but the two things that I can think of are both tox-related. They might have seen further data from the human trials that showed something unexpected, although I think that’s unlikely, or they might have seen something bad in a long-term animal study. I recall some PPAR alpha-gamma compounds abruptly dropping out of the clinic some years ago because of this sort of thing (two-year rodent tox).
The folks at Celgene will be very interested to hear anything they can, you can count on that. If this was a tox signal (and I think that’s the likely problem), then the first question is always “mechanism-related or compound-related?” Not always an easy question to answer, that, but it’ll be crucial.