NGM Bio leaps on positive top-line aldafermin trial in NASH

US biotech NGM Biopharmaceuticals (Nasdaq: NGM) yesterday announced positive preliminary top-line results for its liver disease candidate aldafermin, sending the firm’s shares rocketing 23.5% to $20.00 in heavy volume by Monday mid-morning, having jumped as much as 41%.

The results were from the 24-week double-blind, randomized, placebo-controlled cohort (Cohort 4) of an adaptive Phase II study evaluating the efficacy, safety and tolerability of 1mg aldafermin (formerly NGM282) in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) with stage 2 or 3 liver fibrosis (F2-F3).

Aldafermin, NGM’s lead wholly-owned drug candidate, is an engineered variant of the human hormone FGF19 being developed as a once-daily treatment for patients with NASH. Cohort 4 was powered to demonstrate the effect of aldafermin treatment versus placebo on the primary endpoint of change in absolute liver fat content (LFC), which achieved statistical significance. In addition, the study assessed secondary and exploratory endpoints of liver histology and biomarkers of disease activity, many of which also achieved statistical significance.