Biotech Values

[mcbio]

Seres S-1: http://www.sec.gov/Archives/edgar/data/1609809/000119312515202059/d816354ds1.htm .

Alternative to fecal transplant for CDI from Seres: spores of those bacteria, isolated from healthy human feces, are put into a pill

Ph1 result from 30 patients:

Quote:
In Seres' trial, 30 patients with recurrent C. difficile, defined as two recurrences or more, were treated in two dose cohorts. Each patient stopped taking antibiotics and was orally administered SER-109 one day later. The primary efficacy endpoint of the study was the absence of recurrent CDI over an 8-week period and safety was assessed by regular phone contact and in-person physical exams. All 15 patients in the first cohort reached the week 8 endpoint without requiring antibiotics and were CDI-free. In the second, lower dose cohort, which is in progress, 14 of the 15 patients enrolled have been successfully treated and are presently CDI free, 11 of whom have achieved the primary 8-week efficacy endpoint thus far. Genomic analysis of each patient's gastrointestinal microbiome, evaluated to date, demonstrates that SER-109 repairs dysbiosis caused by antibiotic treatment.

My big question on this data is how much we can trust it given that I understand this was a single-arm trial.