Biotech Values

[ghmm]

In IPF, it seems likely that the Fibrogen drug works only in a subset of patients (maybe 25%), but when it does work, it works really well. So that complicates trial design some, and if you add another drug in combination things get even more complex.

I recall Intermune saying (at least in the successful CAPACITY study I suspect also for ASCEND but not certain) the decline that drove significance in their trials was driven by a small portion (I think ~20%) of the patients with most having little ( < 10%) or no decline. My stats background is limited to speculate what type of magnitude improvement would be needed and what size trial. I imagine it would need to be fairly large to obscure some of the large variability in IPF patients.

Perhaps IPF is actually a bunch of different diseases with some common symptomatology, or perhaps there are some genetic differences.

It seems like every couple years we talk about IPF and you or are I mention this. I certainly agree. While the companies site 2-5 year survival from diagnosis I suspect the standard deviation is quite high. Anecdotally I've seen patients who believe they've had the disease for 2 decades. For some related (I)PF's (e.g. genetic, secondary to HPS) it seems the disease has a different progression sadly striking at a much younger age so I strongly believe IPF will turn out to be many diseases. That is why I like broad acting anti-fibrotics until the disease is better understood.