Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Technical Presentation (December 2017)
25 slides from Galectin Therapeutics's technical presentation, Dec 5, 2017
Slide 1: NASH-CX Clinical Trial Top Line Results
NASH-CX Clinical Trial Top Line Results December 5, 2017 NASDAQ: GALT www.galectintherapeutics.com 2017 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future performance and use words such as “may,” “estimate,”
Slide 3: Summary: NASH-CX Clinical Trial Results in Patients with NASH Cirrhosis
Summary: NASH-CX Clinical Trial Results in Patients with NASH Cirrhosis A statistically significant and clinically meaningful effect of GR-MD-02 was observed on the primary endpoint measurement of HVPG1 in the subgroup of NASH2 cirrhosis patients without esophageal varices (81 patients or 50% of tot
Slide 4: Background: Drug Development Program with GR-MD-02
Background: Drug Development Program with GR-MD-02 GR-MD-02 is a galectin-3 inhibitor that reverses fibrosis, reduces cell death and inflammation, and decreases portal pressure of cirrhosis, in rodent models of NASH fibrosis1 and toxin-induced liver cirrhosis2 NASH3 is a chronic disease with progres
Slide 5: Liver (Portal Vein) Blood Pressure is Critical in Patients with NASH Cirrhosis
Liver (Portal Vein) Blood Pressure is Critical in Patients with NASH Cirrhosis Cirrhosis (liver biopsy histology) Increasing amounts of fibrotic tissue and distorted architecture over time Normal HVPG1 (0-5 mm Hg) Mild Portal Hypertension (≥ 6 and < 10 mm Hg) NASH Clinically Significant Portal Hyper
Slide 6: Critical Importance of Esophageal Varices in NASH Cirrhosis
Critical Importance of Esophageal Varices in NASH Cirrhosis Esophagus: No Varices Esophageal Varices Bleeding Esophageal Varices
Slide 7: NASH-CX Clinical Trial Design
NASH-CX Clinical Trial Design1 Every other week infusion X 26 Placebo (54) GR-MD-02 2 mg/kg (54) GR-MD-02 8 mg/kg (54) NASH cirrhosis (biopsy) HVPG ≥ 6 mmHg No cirrhosis complications No or small varices HVPG2 Liver Biopsy3 FibroScan MBT4 Complications5 Endoscopy X X X X X X X X X X X X X X 1 All su
Slide 8: Patient Populations
Patient Populations Patients Screened: N = 290 Screening Failures N = 128 Baseline Esophageal Varices N = 80 (ITT/LOCF) No Baseline Esophageal Varices N = 81 (ITT/LOCF) 1 Discontinued before 1st dose 10 Discontinued during dosing without end of study HVPG CSPH N = 67 MPH N = 13 CSPH N = 41 MPH N = 4
Slide 9: Percent Change from Baseline HVPG
Percent Change from Baseline HVPG Data Expressed as Change in Absolute Value and Percent Change From Baseline Hepatic Venous Pressure Gradient 0 mmHg 5 mmHg 10 mmHg Normal Mild Portal Hypertension (MPH) Clinically Significant Portal Hypertension (CSPH) Many relevant clinical observations have been m
Slide 10: HVPG Primary Endpoint: Total Patient Population
HVPG Primary Endpoint: Total Patient Population1 (Mean baseline HVPG 12.2 mmHg) PLB GR2 GR8 8% -1% -2% There was a 0.8 mmHg and 10% difference between placebo and the GR8 treatment group, but the differences did not reach statistical significance n=54 n=53 n=54 Mean ± SEM Percent Change in HVPG from
Slide 11: Percent Change in HVPG in NASH Cirrhosis Without Varices at Baseline
PLB GR2 GR8 Percent Change in HVPG from baseline to week 54 HVPG in NASH Cirrhosis Without Varices at Baseline1 (Mean baseline HVPG 10.6 mmHg) 12% -9.0% 0.5 % p=0.01 p=0.17 n=33 n=25 n=23 Mean ± SEM The drug effect was significantly dependent on the presence of varices at baseline (p<0.02). Analysis
Slide 12: Mild Portal Hypertension Without Varices at Baseline
PLB GR2 GR8 Percent Change in HVPG from baseline to week 54 Mild Portal Hypertension Without Varices at Baseline1 (Mean baseline HVPG 7.8 mmHg) In the absence of varices and with mild portal hypertension, there was statistically significant treatment effect on HVPG in both dose groups ANCOVA 1ITT wi
Slide 13: Clinically Significant Portal Hypertension Without Varices at Baseline
PLB GR2 GR8 Percent Change in HVPG from baseline to week 54 Clinically Significant Portal Hypertension Without Varices at Baseline1 (Mean baseline HVPG 13.4 mmHg) Mean ± SEM In the absence of varices and with clinically significant portal hypertension, there was a statistically significant treatment
Slide 14: Responder Analysis: Clinically Significant Reductions in HVPG
Responder Analysis: Percentage of Patients Without Varices at Baseline who have Clinically Significant Reductions in HVPG 1 Chi Square statistical analysis Percent 15% 44% 17% PLB GR2 GR8 p = 0.021 Percent Responders with HVPG Reduction from Baseline of ≥ 2 mm Hg Percent Responders with HVPG Reducti
Slide 15: Statistically Significant Improvement of Hepatocyte Ballooning on Liver Biopsy
Statistically Significant Improvement of Hepatocyte Ballooning on Liver Biopsy PLB GR2 Change in hepatocyte ballooning score at week 54 The activity NASH is assessed by the NAFLD1 Activity Score (Ballooning hepatocytes, inflammation and fat) We observed a trend reduction in NAS in treatment groups a
Slide 16: Cirrhosis Complications
Cirrhosis Complications1 Patients with at least one complication PLB GR2 GR8 Comments All Patients: Intention to Treat (n=161) 7 7 6 No difference between groups No Baseline Esophageal Varices (n=81) 5 3 1 No difference between groups New Esophageal Varices 3 0 0 p = 0.032, PLB vs GR2 + GR8 Clinical
Slide 17: Safety Results
Safety Results Total (n=162) PLB (n=54) GR2 (n=54) GR8 (n=54) All adverse events 1422 464 541 417 Grade 3-4 (patients (total events)) 31 (69) 10 (19) 10 (22) 11 (28) SAE1 (patients (total events)) 25 (39) 9 (13) 5 (10) 11 (16) Rx stopped due to AE 5 0 0 52 Death 1 0 13 0 Grade 3/4 lab (patients (tot
Slide 18: Major Conclusions from NASH-CX Clinical Trial Results
Major Conclusions from NASH-CX Clinical Trial Results This trial demonstrated that GR-MD-02 had a statistically significant and clinically meaningful effect in reducing the primary endpoint measurement of HVPG in the subset of patients with NASH cirrhosis who did not have baseline esophageal varices
Slide 19: Discussion of Key Questions Raised by the Study Results
Discussion of Key Questions Raised by the Study Results Why is there a differential effect of GR-MD-02 therapy in patients with and without esophageal varices? Liver biopsy showed an effect in all patients, so GR-MD-02 had a therapeutic benefit regardless of varices The sensitivity and variability o
Slide 20: NASH-CX Trial: Next Steps
NASH-CX Trial: Next Steps The trial results identify a significant patient population who may benefit from treatment with GR-MD-02 Patients with well-compensated NASH cirrhosis without esophageal varices Patients are readily identifiable since upper endoscopy for varices is recommended for all those
Slide 21: Appendix
Appendix NASDAQ: GALT www.galectintherapeutics.com 2017 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com
Slide 22: Appendix 1: Deep Gratitude to Patient Volunteers and Clinical Study Sites
22 Appendix 1: Deep Gratitude to Patient Volunteers and Clinical Study Sites
Slide 23: Appendix 2: Study Demographics
Appendix 2: Study Demographics1 Total (FAS2) (162) PLB3 (n=54) GR23 (n=54) GR83 (n=54) Age, years; Median (IQR) 59 (52, 65) 59 (53, 64) 60 (53, 65) 58 (51, 63) Female, n (%) 113 (70) 36 (67) 34 (63) 43 (79) White, n (%) 132 (81) 46 (85) 46 (85) 40 (74) Hispanic/Latino, n (%) 28 (17) 8 (15) 7 (13) 13
Slide 24: Appendix 3: HVPG at Baseline are Comparable Between Treatment Groups
Appendix 3: HVPG at Baseline are Comparable Between Treatment Groups1 Mean ± SD (n) Total PLB GR2 GR8 Hepatic Venous Pressure Gradient HVPG (mm Hg) 12.2 ± 4.1 (162) 11.6 ± 3.9 (54) 12.3 ± 4.3 (54) 12.7 ± 4.2 (54) CSPH2 (mm Hg) 14.3 ± 3.4 (109) 13.8 ± 3.1 (34) 14.2 ± 3.9 (37) 14.8 ± 3.1 (38) MPH3 (mm
Slide 25: Appendix 4: Effect of Drug Treatment on NAFLD Activity Score
Appendix 4: Effect of Drug Treatment on NAFLD1 Activity Score ns PLB GR2 Change in NAS at week 54 The NAFLD1 Activity Score (NAS) is the widely accepted way to evaluate liver biopsies for the severity NASH disease activity, absent an evaluation of liver fibrosis NAS is comprised of three components
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