A phase 2b trial of NGM Biopharmaceuticals’ aldafermin in nonalcoholic steatohepatitis (NASH) has missed its primary endpoint, sending shares in the biotech tumbling. NGM has pulled plans to enter phase 3 in light of the midstage failure of the FGF19 analog.
California-based NGM ramped up expectations for aldafermin last year when it delivered midphase data linking the drug to a significant reduction in absolute liver fat content and improvements on a clutch of other measures. Yet, like other NASH drug developers before it, NGM has now found that a positive biomarker result can fail to translate into improvements in histology outcomes.
Author: Canan Schuman, PharmD/PhD
Canan Schumann is Chief Editor for Axxiem and for Axxiem's blog "BiotechOntheWeb". When not writing for Axxiem, Canan works as a Clinical Research Scientist II at the Research and Development Department at Molecular Testing Labs, developing endpoint assays for the detection of infectious disease and cancer. Canan currently resides in Portland, Oregon, where he received his Honors Bachelor of Science (HBS), Doctor of Pharmacy (PharmD.), and his Doctor of Philosophy (Ph.D.) in Biopharmaceutics at Oregon State University.