Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Shareholder Meeting (December 2019)
27 slides from Galectin Therapeutics's shareholder meeting presentation, Dec 4, 2019
Slide 1: Corporate Update – focused on NASH Cirrhosis
Corporate Update – focused on NASH Cirrhosis Annual Stockholders Meeting December 4, 2019
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others
Slide 3: Outline of Today's Presentation
Outline of Today’s Presentation Belapectin (GR-MD-02) and NASH CIRRHOSIS • Highlights of NASH-CX Phase 2 study • The road to Adaptively-Designed (Phase 2b/Phase 3) NASH-RX trial start • Regulatory input and recent FDA interactions • Revised study design • Benefits and risks • Sites & study status •
Slide 4: Targeting NASH Cirrhosis – Cirrhosis Stage
Targeting NASH Cirrhosis – Cirrhosis Stage Progression to Progression Cirrhosis (5%) to Varices Cirrhosis Stage1 Stage 1 Stage 2 Stages 3 and 4 NASH: Clinical Compensated Compensated Decompensated Cell Death No varices or Varices present Complications Fatty Liver complications Inflammation Hemodynam
Slide 5: Critical Importance of Esophageal Varices in NASH Cirrhosis
Critical Importance of Esophageal Varices in NASH Cirrhosis An important goal of treatment of patients with Stage 1, compensated cirrhosis without esophageal varices is to prevent progression to varices and complications “No varices means no potential for bleeding varices” Esophagus: No Varices Esop
Slide 6: The NASH-CX Trial
Highlights of results THE NASH-CX TRIAL © 2019 Galectin Therapeutics | NASDAQ:GALT 6
Slide 7: Belapectin (GR-MD-02) Development Program: Summary
Belapectin (GR‐MD‐02) Development Program: Summary • Gal‐3 null mice are resistant to development of NASH 1 and liver fibrosis 1, 2 • GR‐MD‐02 is a glycopolymer (polysaccharide), considered a Nonbiological Complex Drug (NBCD) that binds to galectin‐3 protein, has strong global patent protection, and
Slide 8: NASH-CX Clinical Trial Design
NASH‐CX Clinical Trial Design1 Major Inclusion Criteria Every other week infusion X 26 NASH cirrhosis (biopsy) Placebo (54) HVPG ≥ 6 mmHg GR-MD-02 2 mg/kg (54) No cirrhosis complications No or small varices GR-MD-02 8 mg/kg (54) Baseline Week 26 Week 54 Primary endpoint HVPG2 X X Liver Biopsy3 X X S
Slide 9: Patient Populations – NASH-CX
Patient Populations – NASH‐CX Patients Screened: N = 290 Screening Failures N = 128 Definitions: ITT = Intention to Treat ITT/LOCF = ITT/Last Observation Carried Forward Patients Randomized: N = 162 mITT= ITT with end of study HVPG PP = Per Protocol 1 Discontinued before 1st dose MPH = Mild Portal H
Slide 10: NASH-CX: HVPG Primary Endpoint
NASH‐CX: HVPG Primary Endpoint Total Patient Population 1. Trend toward benefit with drug, but not statistically significant 2. Drug effect was significantly dependent on dose*varices in total group (p<0.02) 3. GR8 dose group, based on pK, was above upper limit of the therapeutic window Mean Change
Slide 11: NASH-CX Patients Without Varices at Baseline
NASH‐CX Patients Without Varices at Baseline (50% of total population) Statistically significant effect of 2 mg/kg dose on absolute change in HVPG Mean Change 0.8 ‐1.08 0.15 p < 0.01 p = 0.36 (Absolute Change) From Baseline to Week 541 p = 0.01 p = 0.17 (Percent Change) HVPG (mmHg) Overall mean base
Slide 12: NASH-CX: Development of New Varices
NASH-CX: Development of New Varices Among patients without varices at baseline, there were more new varices in the placebo group than in the GR2 group Chi-Square analysis used for comparisons © 2019 Galectin Therapeutics | NASDAQ:GALT 12
Slide 13: NASH-CX: HVPG in Patients Without Varices and Mild Portal Hypertension
NASH‐CX: HVPG in Patients Without Varices at Baseline and Mild Portal Hypertension Both the GR2 and GR8 treatment groups had a statistically significant effect on the percent change in HVPG in patients without varices and MPH © 2019 Galectin Therapeutics | NASDAQ:GALT 13
Slide 14: NASH-CX: HVPG in Patients Without Varices and Clinically Significant Portal Hypertension
NASH‐CX: HVPG in Patients Without Varices at Baseline and Clinically Significant Portal Hypertension (HVPG >10 mmHg) Like the MPH group shown earlier, in patients with CSPH, the GR2 group showed a statistically significant reduction in HVPG when compared to placebo © 2019 Galectin Therapeutics | NAS
Slide 15: NASH-CX: Major Conclusions
NASH‐CX: Major Conclusions • GR‐MD‐02 had a statistically significant and clinically meaningful effect in reducing HVPG in patients with NASH cirrhosis who did not have baseline esophageal varices (50% of total patient population) • Important drug effect in the total study population on liver biopsy
Slide 16: Adaptively-Designed Phase 2b/3 Trial of Belapectin in NASH Cirrhosis
The NASH-RX trial Adaptively-Designed Phase 2b/3 Trial of Belapectin in NASH Cirrhosis © 2019 Galectin Therapeutics | NASDAQ:GALT 16
Slide 17: There is light at the end of the tunnel
The Road to Phase 3 is often a Long Path There is light at the end of the tunnel © 2019 Galectin Therapeutics | NASDAQ:GALT 17
Slide 18: Road to Phase 3: Sequence of Events and Highlights
Road to Phase 3: Sequence of Events and Highlights • Feb 2019 - FDA Meeting • Purpose: Discuss potential surrogate endpoint of progression to varices for Phase 3 trial • Indicated supportive of “the potential use of progression to varices as a surrogate endpoint and progression to large varices (or
Slide 19: © 2019 Galectin Therapeutics | NASDAQ:GALT
© 2019 Galectin Therapeutics | NASDAQ:GALT 19
Slide 20: NASH-RX: Adaptively-Designed Phase 3 Study in NASH Cirrhotics
NASH-RX: Adaptively-Designed Phase 3 Study in NASH Cirrhotics Subject to Change Randomize additional patients 12-18 Month 12—18 Month Double-blind Phase 2b Double-blind Phase 3 Key eligibility criteria Phase 4 begins before marketing application 1. NASH cirrhosis 2. Without varices 3. CTP score <7 G
Slide 21: NASH-RX: Segment 1 - Features
NASH-RX: Segment 1 - Features • Inclusion/Eligibility Criteria • NASH cirrhosis • No varices • CTP score < 7 (Class A) • Clinical signals suggesting portal hypertension with at least 2 of: • Thrombocytopenia • Spleen size ≥ 15 mm • Evidence of collaterals by imaging • Double-blind • Duration 12-18 m
Slide 22: Key Feature of NASH-RX Design at End of Segment 1
Key Feature of NASH-RX Design at End of Segment 1 Interim Analysis (DMC) to inform Phase 3 • Interim Analysis informs: • Primary EP: Incidence of varices • Confirms dose selection from NASH-CX results and dose adjustment • Informs a single dose into Phase 3 • Event rate allows ‘right-sizing’ of Phas
Slide 23: NASH-RX: End of Segment 2
NASH-RX: End of Segment 2 Accelerated approval application • Accelerated approval • Primary Endpoint • Development of new varices • Secondary Endpoints • Proportion of patients with large varices or red wales • Varices requiring treatment • Decompensation events • All-cause mortality • MELD > 15 in
Slide 24: NASH-RX: Adaptively-Designed P3 Trial Feature, Benefits and Risks
NASH-RX: Adaptively-Designed P3 trial Feature, Benefits and Risks • Study features potentially improving likelihood of showing Drug effects • Clarity and reaffirmation of NASH-CX efficacy & safety • Appropriate selection of dose – e.g., single dose (2 or 4 mg/kg) for P3 or both • Hepatic Impairment
Slide 25: NASH-RX: Current Study Status
NASH-RX: Current Study Status • Sites qualified by Covance • ~130 sites in 12 countries • Revisiting sites passed over due to biopsy, EGD testing frequency and HVPG requirements of earlier study design • Sites being kept informed of status of study start • Work completed for • NASH-specific site net
Slide 26: NASH-RX: Additional Considerations & Next Steps
NASH-RX: Additional Considerations & Next Steps • There is a delay due to modifying the protocol and resubmitting to FDA • Change in first patient first visit to late Q1, 2020 • Sites have been informed to maintain their interests • Costs being reassessed • Elimination of HVPG subgroup and reduced f
Slide 27: Thank You
THANK YOU © 2019 Galectin Therapeutics | NASDAQ:GALT 27
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