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NGMBIO NGM Bio Reports Topline Results from 24 - Week Phase 2b ALPINE 2/3 Study of Aldafermin in NASH May 24 , 2021 • Study did not meet primary endpoint of fibrosis improvement by ≥1 stage with no worsening of NASH versus placebo • Statistical significance achieved versus placebo on certain secondary endpoints , including NASH resolution ( at the 3 mg dose ) and multiple non - invasive measures of NASH , including liver fat content reduction by MRI - PDFF , ALT , AST and Pro - C3 ( at the 1 mg and 3 mg doses ) • Aldafermin was generally well tolerated with an overall safety profile similar to placebo • NGM plans not to pursue Phase 3 clinical development of aldafermin in F2 / F3 NASH ; will focus on its growing ophthalmology and oncology portfolio . Company to host conference call and webcast today at 8:30 a.m. ET ( 5:30 a.m. PT ) SOUTH SAN FRANCISCO , Calif . , May 24 , 2021 ( GLOBE NEWSWIRE ) -- NGM Biopharmaceuticals , Inc. ( NGM ) ( Nasdaq : NGM ) , a biotechnology company focused on discovering and developing transformative therapeutics for patients , today reported results from the 24 - week Phase 2b ALPINE 2/3 study evaluating aldafermin in 171 patients with biopsy - confirmed non - alcoholic steatohepatitis ( NASH ) with stage 2 or 3 liver fibrosis ( F2 / F3 ) . The trial was an equally randomized , double - blind , placebo - controlled study that assessed the efficacy , safety and tolerability of 0.3 mg , 1 mg and 3 mg doses of aldafermin once - daily subcutaneous injections compared to placebo . The study did not meet its primary endpoint evaluating a dose response showing improvement in liver fibrosis by ≥1 stage with no worsening of NASH at week 24 ( p = 0.55 ) , analyzed using a dose response - driven statistical analysis plan ( Multiple Comparison Procedure Modeling , or MCP - Mod ) . The study did achieve statistical significance versus placebo on certain secondary endpoints , including NASH resolution ( at the 3 mg dose ) and multiple non - invasive measures of NASH , including liver fat content reduction by MRI - PDFF , ALT , AST and Pro - C3 ( at the 1 mg and 3 mg doses ) . " These results are certainly disappointing , particularly given the dire unmet need in this patient population . The lack of significant fibrosis improvement was unexpected given the consistency of histology findings previously seen with aldafermin in our adaptive four - cohort Phase 2 study , " said David J. Woodhouse , Ph.D. , Chief Executive Officer at NGM . " However , in line with the data from that study , ALPINE 2/3 achieved statistical significance on multiple non - invasive measures of NASH at the two higher doses . That said , given the failure to meet the primary endpoint , we have decided to shift resources that had previously been reserved for a Phase 3 F2 / F3 NASH development program toward advancing our other programs . " Dr. Woodhouse further commented , " NGM is a markedly different company than when we initiated ALPINE 2/3 in May 2019 , when our clinical - stage pipeline consisted primarily of liver and metabolic programs . Over the past two years , we have steadily expanded that pipeline with programs generated from our productive in - house discovery engine , and today we are also an ophthalmology and oncology company with four Phase 2 programs underway . We look forward to advancing our clinical programs and moving additional programs into the clinic , supported by our cash balance that was in excess of $ 400 million at the end of the first quarter . " NGM's disclosed pipeline includes : NGM621 , an anti - complement C3 antibody , currently in Phase 2 development for the treatment of geographic atrophy ; NGM120 , a GFRAL antagonistic antibody in Phase 2 development for the treatment of metastatic pancreatic cancer and cancer - related cachexia ; and NGM707 and NGM438 , anti - ILT2 / ILT4 and LAIR1 myeloid checkpoint candidates , respectively , both of which are anticipated to begin Phase 1 studies for the treatment of advanced solid tumors this year . Additionally , Merck continues to progress a global Phase 2b study of MK - 3655 , an FGFR1c / KLB agonistic antibody for the treatment of NASH , which was discovered by NGM under its collaboration with Merck . ALPINE 2/3 Topline Findings - Secondary Analyses of Key Histology Measures Summary of ALPINE 2/3 Histology Data ( pairwise ) + Placebo ( n = 36 ) Aldafermin 0.3 mg ( n = 36 ) Aldafermin 1 mg ( n = 34 ) Aldafermin 3 mg ( n = 37 ) Fibrosis Improvement ≥1 Stage with No Worsening of NASH1 19 % 31 % 15 % 30 % NASH Resolution with No Worsening of Fibrosis² 6 % 11 % 18 % 22 % * Fibrosis Improvement and NASH Resolution³ 3 % 11 % 9 % 14 % * p≤0.05 ± Analyzed using a pre - specified , pairwise statistical analysis plan ; per protocol includes only those patients who completed both baseline and week 24 biopsies ( n = 143 ) 1 Defined as patients who have an improvement in liver fibrosis by ≥1 stage with no worsening of NASH ( no worsening of steatosis , lobular inflammation or hepatocyte ballooning grade ) from baseline to W24 2 Defined as patients having a NAS score of 0 or 1 for inflammation and 0 for ballooning , with no worsening of fibrosis ( no progression of NASH CRN fibrosis stage ) from baseline to W24 ; NAS refers to the non - alcoholic fatty liver disease ( NAFLD ) activity score , which is comprised of three components : steatosis , lobular inflammation and hepatocellular ballooning 3 Defined as patients who have an improvement in liver fibrosis by ≥1 stage AND have a NAS score of 0 or 1 for inflammation and 0 for ballooning and