NGM Biopharma Shares Spike Higher On Positive NASH Study Results

NGM Biopharmaceuticals Inc NGM is advancing strongly on above-average volume Monday following a positive clinical data readout.

What Happened

California-based NGM, which IPOed last March, announced positive preliminary top-line results from Cohort 4 of an adaptive Phase 2 study that evaluated the efficacy, safety and tolerability of 1mg aldafermin in patients with biopsy-confirmed non-alcoholic steatohepatitis, or NASH, with stage 2 or 3 liver fibrosis.

Aldafermin is an engineered variant of human hormone FGF19, being developed as a once-daily treatment for patients with NASH.

The Cohort 4 was designed to demonstrate the effect of aldafermin treatment versus placebo on the primary endpoint of change in absolute liver fat content.

The investigational therapy also achieved statistical significance in many of the secondary and exploratory endpoints of liver histology and biomarkers of disease activity. The company also noted that aldafermin was generally well tolerated, with no study withdrawals due to adverse events.

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Why It's Important

NASH currently has no FDA-approved drug and several biopharma companies, both big and small, are engaged in developing a drug.

"To my knowledge, aldafermin is the first drug to demonstrate a robust, statistically significant effect of greater than 20% of patients achieving the FDA composite regulatory endpoint of fibrosis improvement and resolution of NASH versus placebo, as well as show an impressive impact on both of these endpoints independently," said Stephen Harrison, the principal investigator on the study. "Moreover, these data further strengthen aldafermin's potential as a transformative monotherapy for NASH patients with established fibrosis."

The company is currently enrolling patients in the Phase 2b ALPINE 2/3 study designed to assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg of aldafermin compared to placebo in patients with biopsy-confirmed NASH and F2-F3 liver fibrosis.

Data from the study is expected in the first half of 2021.

Additionally, NGM said it plans to initiate the Phase 2b ALPINE 4 study to evaluate aldafermin in NASH patients with F4 liver fibrosis and well-compensated cirrhosis, in the first half of 2020.

NGM shares are rallying 18.5% to $19.19 at time of publication.