NGM Bio Announces Publication In The Lancet Of Phase 2 Study Of NGM282 In NASH Patients And Upcoming Presentations Of NGM282 NASH Histology Data And NGM282 PSC Data At The International Liver Congress 2018
March 12th 2018
The Lancet publishes findings from groundbreaking 12-week Phase 2 study of NGM282 in non-alcoholic steatohepatitis (NASH) patients employing non-invasive measures of disease activity
- Statistically significant and clinically meaningful improvements observed in MRI measures of liver fat and serum biomarkers of liver function, lipid metabolism and fibrosis
Results of a subsequent 12-week Phase 2 study of NGM282 demonstrating histological responses in NASH patients selected for podium presentation at April EASL meeting
- Improvements observed in both fibrosis and non-alcoholic fatty liver disease (NAFLD) activity score (NAS)
SOUTH SAN FRANCISCO, March 12, 2018 – NGM Bio today announced multiple milestones for NGM282, an experimental medicine for the treatment of NASH. The company confirmed that results from an exploratory 12-week Phase 2 clinical trial of NGM282 in NASH patients, which revealed improvements in histological measures of disease, were accepted for oral presentation at the International Liver Congress™ 2018, the 53rd annual meeting of the European Association for the Study of the Liver (EASL), to be held April 11-15, 2018 in Paris, France. In addition, the outcome of a Phase 2 clinical trial of NGM282 in primary sclerosing cholangitis (PSC) patients, demonstrating significant improvements in markers of fibrosis and hepatic injury, will be presented in the Late Breaker session at the same meeting. Presentation details are as follows:
Title: NGM282 improves fibrosis and NASH-related histology in 12 weeks in patients with biopsy-confirmed NASH, which is preceded by significant decreases in hepatic steatosis, liver transaminases and fibrosis markers at 6 weeks
Presenter: Stephen Harrison
Session Date and Time: Saturday, April 14, 2018 at 10:15 a.m. – 10:30 a.m. (local time)
Session: General Session III
Title: NGM282, an Engineered Analogue of FGF19, Significantly Improves Markers of Bile Acid Synthesis, Hepatic Injury and Fibrosis in PSC Patients: Results of a Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Presenter: Gideon Hirschfield
Session Date and Time: Saturday, April 14, 2018 at 4:15 p.m. – 4:30 p.m. (local time)
Session: Late Breaker Session
Location for Both Sessions: Paris expo Porte de Versailles – Pavillon 7, 1 Place de la Porte de Versailles, Paris, France
The company also confirmed the publication of a study in The Lancet detailing the results of a previously announced study of NGM282 in NASH patients, entitled: “NGM282 for treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled phase 2 trial”.
“The dramatic impact of NGM282 on non-invasive imaging and biomarker measures associated with the resolution of NASH and reversal of fibrosis in a 12-week, double-blind, placebo-controlled study is now detailed in full in The Lancet,” said Alex DePaoli, M.D., Chief Medical Officer of NGM Bio. “Separately, we look forward to sharing with the medical community at EASL data from a subsequent study designed to demonstrate that the imaging and biomarker benefits delivered by NGM282 translate to improvements in fibrosis and liver histology in well-established NASH patients.”
About the Phase 2 NASH Program
The Phase 2 program includes two studies: (1) a 12?week, randomized, double?blind, placebo?controlled multi-center study that assessed the efficacy and safety of NGM282 3 mg and 6 mg once daily vs. placebo in adults with biopsy?confirmed NASH; and (2) a 12-week, single-blind study that assessed the efficacy and safety of NGM282 0.3 mg, 1 mg and 3 mg once daily in a similar patient population. Key eligibility criteria were similar in both studies and included NAFLD Activity Score ≥ 4 (with at least one point in each component of steatosis, lobular inflammation and hepatocellular ballooning), stage 1?3 fibrosis and ≥ 8% liver fat content (LFC) via magnetic resonance imaging–proton density fat fraction (MRI-PDFF).
The primary endpoint in both studies was the change from baseline to week 12 in absolute LFC as measured by MRI-PDFF. Secondary outcomes included absolute and relative change in LFC at week 6, relative change in LFC at week 12, normalization of LFC (defined as proportion of patients with a value of ≤ 5%) at week 12, changes from baseline and normalization in ALT levels, changes in lipids and lipoprotein particles and safety and tolerability of NGM282. Exploratory outcomes included assessment of serum fibrosis biomarkers, including released N?terminal pro?peptide of type III collagen (PRO?C3), total enhanced liver fibrosis (ELF) score and multi-parametric imaging with LiverMultiScan™.
In addition to the above outcomes, a histological assessment was conducted after 12 weeks of treatment in the 3 mg NGM282 cohort of the Phase 2 open-label study. A blinded reading of pooled biopsies was used to evaluate changes in fibrosis stage and NAS from baseline after 12 weeks of NGM282 treatment.
Approximately 20% of NAFLD patients develop NASH, a chronic disease characterized by a buildup of fat in the liver, inflammation and cell damage that can cause fibrosis and scarring of the liver. Frequently correlated with a poor diet, obesity and type 2 diabetes, NASH can lead to cirrhosis, liver cancer, organ failure and, absent a liver transplant, death. Experts estimate that approximately 3% to 12% of adults in the United States, and as many as 400 million people worldwide, have NASH. There are currently no approved therapies for the disease.
NGM282 is a non-tumorigenic, engineered variant of the human hormone FGF19 that dramatically reduces liver fat content, improves liver function and reverses biomarkers of fibrosis by targeting multiple pathogenic pathways of NASH. NGM Bio has generated robust preclinical and clinical evidence supporting NGM282’s ability to significantly improve steatosis, inflammation and fibrosis. This wholly-owned, single-agent therapeutic has been evaluated in four Phase 2 studies in primary biliary cholangitis, primary sclerosing cholangitis, type 2 diabetes and NASH. NGM282’s safety database includes clinical data from more than 350 individuals.
About NGM Bio
NGM Bio is a research-driven biotechnology company committed to discovering and developing novel biologics for the treatment of life-threatening diseases. NGM Bio’s portfolio consists of multiple programs in clinical testing and more than a dozen additional programs in various stages of preclinical development. The company’s most advanced compound, NGM282, is a wholly-owned asset that is in Phase 2 testing for NASH. NGM Bio has established a broad strategic collaboration with Merck. NGM Bio is backed by The Column Group, Merck, Prospect Ventures, Topspin Partners, Rho Ventures, Tichenor Ventures and other leading investors around the world. For more information, please visit www.ngmbio.com.