Biotech Values

[iwfal]

ESPR

There are a lot of people on Twitter talking down the ETC-1002 results, but they impressed the hell out of me.

As Larry Huston (Forbes) has noted for a while, it is likely that the Ezetimibe outcomes trial (IMPROVE IT) will be a significant factor in what the FDA demands going forward for cholesterol drugs. Reminder that their doubts were strong enough that they reneged on their SPA for trig lowering. If IMPROVE IT fails it seems virtually assured that outcomes will be required (as monotherapy 1002 doesn't lower LDL much more than Ezetimibe)

Personally I think that the efficacy shown by 1002 is made somewhat more credible because it lowered both LDL and CRP. But that is hardly conclusive and probably won't count for much from a regulatory perspective.

BTW if I had to wager on what drug currently in trials would have the largest effect on outcomes it would be ISIS' ApoC3 drug because it shows strong efficacy on a multitude of Met Syndrome markers. Indicating it is getting near the causative nexus (so far 1002 is only 2). It also doesn't hurt that the epi data for heterozygous ApoC3 patients have much lower heart disease and indicators in every epi study.