04 September 2017

Where In the World Is...

Being New Englander, born, bred, and mostly resident for most of my life; I have an inherent trust in pharma that live here. The Boston, Cambridge, 128 corridor companies especially. On the other hand, San Diego outfits seem to more often end up looking a tad shady. Or, at least, seem to fail more often. This is just the latest.
Otonomy (OTIC) stock crashed to a record low Wednesday after its Meniere's disease drug failed to reduce vertigo in a Phase 3 trial -- prompting the biotech to scrap its development.

Scrapping a failed drug is not completely unique; the worst offenders claim some subset responded very well, and the company will pursue the drug with further study. blah, blah, blah. Issue more shares, and the CxO class keep living well.

What's worse, sometimes (again, it seems epidemic in San Diego) a Phase III trial will proceed even when the Phase II was marginal at best. Here's what they had to say about the Phase II trial, that justified continued development of the drug:
Otonomy has completed a randomized, prospective, double-blind, placebo-controlled single-dose Phase 2b trial in a total of 154 Meniere's disease patients. Results indicate that OTO-104 narrowly missed the primary efficacy endpoint (p=0.067) but achieved statistical significance (p<0.05) for multiple prospectively defined secondary vertigo endpoints at multiple time points. Based on these results Otonomy intends to initiate two parallel Phase 3 trials, with one of the trials expected to begin by the end of 2015 and the second trial expected to begin during the first quarter of 2016. OTO-104 is also being evaluated in a multiple-dose safety study in the United Kingdom in patients with Meniere's disease, and enrollment has been completed with a total of 128 patients.

IOW, we missed, but we're going to plow ahead anyway. The Phase III came in with a p-value on the primary of... .62. That's not just a whiff. Very San Diego. I often wonder what scientists who work for such companies think about when they go to beddy bye at night? Same for the biostats who have to make a legitimate narrative from the data. When it's this bad, there's nothing to do but look for another micro-cap pharma in need of a number cruncher.

And, not for nothing, the drug was yet another old one re-purposed. That and Orphan Drug are the increasingly common paths in drugs these days.

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