The Interna*onal Liver Congress Amsterdam, Netherlands 22 April 2017
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1 NGM282, a Novel Variant of FGF19, Significantly Reduces HepaAc Steatosis and Key Biomarkers of NASH: Results of a Phase 2, MulAcenter, Randomized, Double-Blinded, Placebo Controlled Trial in Biopsy-Confirmed NASH PaAents Stephen A. Harrison, Manal F. Abdelmalek, James F. TroRer, Angelo H. Paredes, Hays L. Arnold, Marcelo Kugelmas, Mustafa R. Bashir, Lei Ling, Stephen J. Rossi, Alex M. DePaoli, Mary E. Rinella, Rohit Loomba The Interna*onal Liver Congress Amsterdam, Netherlands 22 April 217
2 Disclosure InformaAon: Relevant Speaker Financial RelaAonships Dr. Stephen Harrison discloses the following relevant financial rela3onships with commercial interests within the past twelve months: Speakers Bureau: Alexion, Gilead Consultant, Advisory Board: Allergan, Chronic Liver Disease Founda3on, Cirius, Echosens, Fibrogen, Galmed, Genfit, Gilead, Intercept, Madrigal, NGM Bio, Novar3s, Perspectum, Pfizer Grant/Research Support: Allergan, Conatus, Galec3n, Galmed, Genfit, Gilead, Immuron, Intercept, Madrigal, NGM Bio, Taiwan J
3 FGF19 Has MulAple Biological AcAviAes Relevant to the Pathogenesis of NASH FGF19 Liver β-klotho FGFR4 β-klotho FGFR1c Insulin Sensi3vity De Novo Lipogenesis FaQy Acid Oxida3on LIVER Reduces Steatosis Reduces Lipotoxicity Reverses SteatohepaAAs Reduces Hepatocellular Injury Decreases Fibrogenesis Toxic FaQy Acids Free Cholesterol Bile Acids DAG/Ceramides
4 NGM282: A Novel Non-tumorigenic, Engineered Variant of Human FGF19 Over 15 variants screened to iden3fy molecules retaining the metabolic ac3vity of FGF19 while elimina3ng the tumorigenic effects Specific amino acid subs3tu3ons remove the IL6/STAT3 ac3va3on associated with FGF19 tumorigenicity Studied in mul3ple animal models of NASH with consistent ac3vity: Normaliza3on of liver enzymes Improvements in all components of NAS An3-fibro3c ac3vity No tumorigenicity Studied in over 275 subjects, including pa3ents with type 2 diabetes, PBC, PSC and NASH
5 Phase 2 Study of NGM282 in NASH: Overview of Study Design SCREENING ON-TREATMENT STUDY PERIOD FOLLOW-UP NGM282 Matched Placebo SC QD NGM282 3 mg SC QD NGM282 6 mg SC QD D -28 D1 W1 W2 W4 W8 W12 W16 - MRI-PDFF - Biopsy MRI-PDFF Randomized, double-blinded, placebo controlled trial Eighty-two subjects enrolled across 18 sites in Australia and the United States Biopsy confirmed NASH with a minimum NAS > 4 (1 point in each component) Stage 1, 2 or 3 fibrosis Minimum 8% absolute liver fat content by MRI-PDFF Abnormal ALT (> 19 IU/L in females; > 3 IU/L in males) Primary endpoint is a decrease in absolute liver fat content > 5%
6 Phase 2 Study of NGM282 in NASH: Baseline Demographics and CharacterisAcs Placebo (n=27) NGM282 3 mg (n=27) NGM282 6 mg (n=28) Mean age, years (SD) 52.8 (11.3) 52. (7.1) 56.4 (7.8) Male, n (%) 7 (25.9%) 11 (4.7) 12 (42.9) White, n (%) 25 (92.6) 25 (92.6) 24 (85.7) Hispanic/LaAno, n (%) 12 (44.4) 8 (29.6) 8 (28.6) DiabeAc, n (%) 17 (63.) 17 (63.) 17 (6.7) Mean weight, kg (SD) 97.6 (19.6) 95.3 (22.6) 98.4 (17.9) Mean BMI, kg/m² (SD) 35.4 (6.) 33.7 (8.6) 34.7 (5.6) Mean ALT, U/L (SD) 71 (42) 67 (54) 62 (34) Mean AST, U/L (SD) 59 (3) 5 (32) 43 (22) Mean MRI-PDFF, % (SD) 16.8 (6.7) 18.1 (7.3) 19.5 (7.8) Mean NAS, n (SD) 5.1 (1.1) 5.1 (1.) 5.1 (.9) Fibrosis stage 1 11 (4.7%) 11 (4.7%) 1 (35.7%) 2 7 (25.9%) 7 (25.9%) 12 (42.9%) 3 9 (33.3%) 9 (33.3%) 6 (21.4%)
7 NGM282 Treated Subjects had a 79% Response Rate with 34% Achieving Normal Liver Fat Content Response = Absolute decrease in liver fat content >5% at 12 weeks NormalizaAon = decrease in absolute liver fat content below 5% at 12 weeks % Response 4% % Placebo (n=27) Normal Abnormal 3 mg (n=27) Response No Response Placebo (.%) 27 (1.%) 3 mg 7 (25.9%) 2 (74.1%) 6 mg (n=26) 6 mg 11 (42.3%) 15 (57.7%) Baseline MRI-PDFF = 24.1% 4% % Week 12 MRI-PDFF = 3.6%
8 Primary Endpoint at Both Doses with Clinically Meaningful Changes in Liver Fat Content Absolute Change RelaAve Change -2 Placebo 3 mg 6 mg Placebo 3 mg 6 mg -1 Absolute Liver Fat (%) p = % Change in Liver Fat p = % of subjects achieved a clinically meaningful >3% rela?ve change Decreases in liver fat strongly correlate with reduc?ons in ALT, AST and C4
9 Greatest Magnitude of Effect in Subjects with Most AcAve Disease: Baseline MRI-PDFF >2% Absolute Change in Liver Fat Content (%) Mean ± SD p = p = % % Placebo (n=8) 3 mg (n=9) 6 mg (n=12) Baseline Wk 12/EW
10 Decreases in ALT at Week 12 Support ReducAons in InflammaAon Absolute Change Percentage Change Placebo 3 mg 6 mg Placebo 3 mg 6 mg ALT (U/L) % Change in ALT p =.951 p = % of subjects normalized ALT, the majority of these by Week 2
11 Rapid and Sustained ReducAons in ALT in PaAents with High Baseline Levels PaAents with a Baseline ALT > 6 U/L ALT (U/L) Placebo (n=11) 3 mg (n=11) 6 mg (n=12) Study Week
12 Decreases in Mean C4 Levels are ReflecAve of Potent CYP7A1 InhibiAon C4 at 24 hrs post-dose (ng/ml), Mean ± SD p = Placebo (n=27) 3 mg (n=27) 6. mg (n=28) Baseline Wk 12/EW 65% were below the LLQ (<.9 ng/ml) 24 hours post-dose at Week 12 C4 = 7α-hydroxy-4-cholesten-3-one
13 Decreased Triglyceride Levels are Consistent with NGM282 Mechanism of AcAon 35 p =.81 Triglycerides (mg/dl), Mean ± SD p=.825 p = Placebo (n=27) 3 mg (n=27) 6 mg (n=28) Baseline Wk 12/EW
14 Increased LDL Levels Reflect the Potent FGFR4-Mediated CYP7A1 InhibiAon 2 LDL-Cholesterol (mg/dl), Mean ± SD p = Placebo (n=27) 3 mg (n=27) 6 mg (n=28) Baseline Week 12 Preclinical and clinical data demonstrate a rapid miagaaon of increased LDL levels within 2 weeks with administraaon of a staan Luo et al. EASL ILC 217 Abstract FRI-353
15 Significant Decreases in PIIINP and TIMP-1 SupporAve of PotenAal AnA-fibroAc AcAvity Significant absolute and percentage change in total ELF score for 3 mg NGM282 cohort with numeric decreases observed with 6 mg cohort No significant changes observed in hyaluronic acid
16 Summary of the Most Common (> 1%) Treatment Emergent Adverse Events Placebo (N=27) ParAcipants (%) Events NGM282 3 mg (N=27) ParAcipants (%) Events NGM282 6 mg (N=28) ParAcipants (%) Events InjecAon site reacaons 2 (7.4%) 3 11 (4.7%) (53.6%) 27 Diarrhea/Loose stools 6 (22.2%) 6 11 (4.7%) 14 1 (35.7%) 13 Abdominal pain 2 (7.4%) 2 8 (29.6%) 9 5 (17.9%) 8 Nausea 1 (3.7%) 2 9 (33.3%) 11 4 (14.3%) 6 Headache 5 (18.5%) 6 3 (11.1%) 5 5 (17.9%) 5 Abdominal distension 1 (3.7%) 1 3 (11.1%) 3 4 (14.3%) 4 VomiAng (.%) 2 (7.4%) 2 5 (17.9%) 6 Frequent bowel movements 2 (7.4%) 2 3 (11.1%) 3 1 (3.6%) 1 Increased appeate (.%) 2 (7.4%) 2 4 (14.3%) 4 ConsApaAon 1 (3.7%) 1 3 (11.1%) 3 1 (3.6%) 1 InjecAon site bruising 3 (11.1%) 3 2 (7.4%) 2 (.%) Weight decreased (.%) (.%) 3 (1.7%) 3 The vast majority of TEAEs were Grade 1 One SAE during study period (acute pancreaaas, possibly related) Adverse event profile is predictable and consistent other NGM282-treated study populaaons
17 Changes in Key Safety and Tolerability Parameters Support ConAnued Development in NASH No significant changes in fas3ng blood glucose or insulin No evidence of renal, hepa3c or hematologic toxicity No evidence of steatorrhea or malabsorp3on secondary to decreased bile acid synthesis No detec3on of neutralizing an3bodies to NGM282 No evidence of drug-induced pruritus Significant weight reduc3on seen with 6 mg vs Placebo (-2.6 kg vs -.7, p =.23) but not at 3 mg dose Decrease in liver fat content appears independent of weight loss
18 Phase 2 Study of NGM282 in NASH PaAents: Summary and Next Steps Primary endpoint met in 79% of NGM282-treated subjects, with over one third of subjects normalizing liver fat content Significant and rapid reduc3ons in mul3ple markers that are relevant to the resolu3on of NASH and improvement in fibrosis No significant difference between 3 mg and 6 mg doses in the overall efficacy parameters; some differences in tolerability Adverse event profile is consistent with other NGM282-treated study popula3ons Further clinical studies are ongoing to evaluate lower doses of NGM282 and the use of sta3ns for mi3ga3on of LDL Data strongly supports con3nued development in NASH
19 Acknowledgements Stuart Roberts Marno Ryan Simone Strasser Jeyamani Ramachandran Manal Abdelmalek Hays Arnold Mustafa Bashir Stephen Caldwell Bradley Freilich Stephen Harrison Kris Kowdley Grisella LaSanta Rohit Loomba Guy Neff Angelo Paredes Mary Rinella Mitch Shiffman James TroQer Alex DePaoli Bryan Baxter Marie Fanget Sam Iki Lei Ling Jian Luo Prerna Menon Tom Parsons Van Phung Stephen Rossi Sandra Russell
EASL International Liver Congress Paris, France 14 April 2018
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