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NGM Bio FGF19 therapy reduces liver fat in patients with NASH-fibrosis
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NGM Bio announced positive interim results from ongoing study of aldafermin, an engineered version of human fibroblast growth factor 19 that demonstrated reductions in liver fat among patients with nonalcoholic steatohepatitis, according to a press release.
“These 24-week findings are highly consistent with the profound impact on liver fat and key biomarkers of NASH that were reported from the three prior 12-week cohorts of this phase 2 study,” Stephen A. Harrison, MD, principle investigator, from Pinnacle Clinical Research and University of Oxford, United Kingdom, said in the release. “The magnitude of effect on [liver fat content] reduction and normalization, combined with the improvement in liver enzymes, reinforce aldafermin’s potential to potently and rapidly reverse multiple aspects of NASH.”
The Cohort 4 phase 2 interim analysis showed that once-daily treatment with aldafermin 1 mg for 24 weeks resulted in greater reductions in absolute liver fat content (–7.9% vs. –2%; P < .05) and relative liver fat content (–39.6% vs. –5.9%; P < .05) compared with placebo among patients with NASH and fibrosis stage 2 or stage 3.
More treated patients achieved a 5% or more absolute reduction in liver fat content (72% vs. 17%), a 30% or more relative reduction in liver fat content (72% vs. 17%), and normalized liver fat content (28% vs. 0%) compared with placebo.
Additionally, treated patients demonstrated clinically meaningful reductions in alanine aminotransferase and aspartate aminotransferase.
Investigators observed no study withdrawals or treatment-related adverse events compared with one withdrawal due to an adverse event and two serious adverse events in the placebo cohort. The most common adverse events among treated patients included mild to moderate diarrhea, headache, nausea and arthralgia.
“Aldafermin continues to be differentiated with what we believe is an industry-leading profile as a monotherapy for the potential treatment of NASH, as few drugs in development for this disease have shown meaningful metabolic, anti-inflammatory and anti-fibrotic activity,” Hsiao D. Lieu, MD, senior vice president and chief medical officer of NGM, said. “Throughout our phase 2 program, we’ve seen a relationship between aldafermin’s impact on biomarkers of disease and subsequent histology results. To that end, we look forward to the biopsy data readout for Cohort 4, which will further inform planning activities for our phase 3 study.”
NGM Bio anticipates topline results in the first quarter of 2020.
Reference: www.ngmbio.com