" The baseline elevation in cCK18 confirmed that the underlying targets of emricasan's mechanism, apoptosis and inflammation, which are believed to drive liver disease progression, were engaged in the NAFLD/NASH patients in this trial. A reduction from baseline in cCK18 at Day 28 of approximately 30% in the emricasan treatment arm and an increase from baseline of approximately 4% in the placebo arm"
"Based on the funds we had available on December 31, 2014 and the additional net proceeds we received in the March 3, 2015 public offering, we believe that we have sufficient capital to fund our anticipated operating expenses for at least 24 months."
NASH data not out yet. Due this quarter. Reason for drop IMO was a very confusing press release about Jan 8. results for acute-on-chronic liver failure (ACLF) that many misread. The data was was Emricasan's seven-fold reduction in biomarker cCK18 over Placebo (54% to 7%) that many misread as 54% to merely 44%. I am a professional writer and it took even I three reads of the release to get it right.
Results for the upcoming Emricasan Phase 2 NAFLD/NASH trial are expected soon -- Q1 of 2015. As reported in CNAT’s Sept. 2, 2014 update presentation, the primary efficacy variable in this trial is change from baseline in ALT. See slide #24.
We already have a compelling example of Emricasan’s ability to change (lower) the ALT from baseline in a VERY big way. Where is that?
As also reported in CNAT’s Sept. 2, 2014 update presentation, in the Phase 2b Dose Response Study in HCV Patients (Study A8491003), Emricasan’s reduction in ALT over placebo in HCV patients was HUGELY statistically significant (stat sig) -- with a “p” value of .0001 (the lower the better). See slide # 12.
I predict the NAFLD/NASH trial results will be similar to the HCV trial results. Stat sig – and out of the park.
“The median reduction [of cCK18] in the 50 mg BID cohort on Day 2 was 54% compared with a median reduction of 7%..in the placebo… cohorts. The observed reduction in cCK18 was maintained in the 50 mg BID cohort (median reduction of 56% and 50% on Day 4 and Day 7”
That is a sustained ninefold increase in reduction in this key biomarker over placebo.
Some on this board have opined that biomarker efficacy results will not likely correspond to clinical results
Given this nine fold improvement, I do not agree with that prediction. Time will tell.