Biotech Values

[DewDiligence]

ENTA reports near-perfect G/P data from portion of CERTAIN-1 study in Japanese patients:

http://finance.yahoo.com/news/enanta-announces-high-svr12-rates-120500217.html

Treatment-naïve GT1 patients without cirrhosis were given 8 weeks of G/P and were analyzed in two subgroups: a) patients without the Y93H variant; and b) patients with the Y93H variant.

Among patients in a), the SVR12 rate was 99% (105/106); the only non-SVR12 patient was one who was lost to follow-up.

Among patients in b), the SVR12 rate was 100% (23/23).

CERTAIN-1 data from non-GT1 patients and various hard-to-treat subgroups will be presented later (at an undetermined medical conference). The ct.g listing for CERTAIN-1 is at https://www.clinicaltrials.gov/ct2/show/NCT02707952 .

CERTAIN-10 is one of ten global phase-3 trials for the G/P regimen, which is under FDA review. Please see #msg-122031014 and #msg-127281791 for related info.