Madrigal Pharmaceuticals, Inc. · NASDAQ:MDGL
Madrigal Pharmaceuticals — Technical Presentation (January 2022)
15 slides from Madrigal Pharmaceuticals's technical presentation, Jan 31, 2022
Slide 1: MAESTRO-NAFLD-1 Topline Data Review
MAESTRO-NAFLD-1 Topline Data Review January 31st, 2022 8-9am EST Resmetirom is an investigational therapy and has not been approved by the FDA (or any other regulatory authority). Resmetirom is only available for use in a clinical trial setting (ClinicalTrials.gov NCT03900429, NCT04197479). NASDAQ:
Slide 2: Forward Looking Statements
Forward Looking Statements This communication contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on our beliefs and assumptions and on information currently available to us but are subject to facto
Slide 3: Agenda
Agenda 1. Introduction Paul Friedman, M.D., Chief Executive Officer 2. MAESTRO-NAFLD-1 Becky Taub, M.D., Chief Medical Officer and Topline Data President of R&D Stephen Harrison, M.D., Medical Director for Pinnacle Clinical Research, San Antonio, Texas, Visiting Professor of Hepatology, Oxford Unive
Slide 4: MAESTRO-NAFLD-1 Topline Data Review
MAESTRO-NAFLD-1 Topline Data Review “These positive results from the first of our two Phase 3 MAESTRO trials support our conviction that resmetirom has the potential to be the first medication approved for the treatment of patients with NASH and liver fibrosis.” - Paul A. Friedman, M.D., Chairman an
Slide 5: Study Design: Randomization
Phase 3 MAESTRO-NAFLD-1 (presumed NASH) Study Design: Randomized, Double-Blind, PBO Controlled with 100 mg Open Label Arm Randomization Placebo 100 mg MRI-PDFF 52 Week Primary FibroScan 80 mg Endpoint LDL-C (lipids) 100 mg Open Label Screening D1 W16 W24 W52 Comparator/Arms ◼ Randomized 1:1:1:1 resm
Slide 6: MAESTRO-NAFLD-1 Patients and Endpoints
MAESTRO-NAFLD-1 Patients and Endpoints ◼ A total of 171 subjects were randomized to the open label non-cirrhotic resmetirom 100 mg 52-week open label arm. All were included in the safety population; 94% and 89% completed key efficacy endpoints at Weeks 24 and 52, respectively. ◼ A total of 972 patie
Slide 7: Study Design
Study Design Randomization MRI-PDFF Placebo FibroScan 100 mg 52 Week Primary LDL-C (lipids) 80 mg Endpoint 100 mg Open Label Screening D1 W16 W24 W52 ◼ Visits were conducted every 4 weeks for 52 weeks on IP with a visit after 4 weeks of follow up off IP (Week 56) ◼ Laboratory and imaging assessments
Slide 8: COVID Impact
COVID Impact Resmetirom Resmetirom Placebo 80 mg 100 mg Randomized (N=327) (N=325) (N=320) Withdrawal by Subject 49 (15.0) 32 (9.8) 39 (12.2) (Other than AE) Lost to Follow-up 24 (7.3) 22 (6.8) 16 (5.0) ◼ MAESTRO-NAFLD-1 was conducted from December 2019 to November 2021 during the height of the COVI
Slide 9: Baseline Characteristics Double Blind population (mITT)
Baseline Characteristics Double Blind population (mITT) Baseline Characteristic Resmetirom Resmetirom Placebo 80 mg 100 mg Number (total = 943)1 320 314 309 Age (SD) 56.2 (11.7) 56.2 (11.5) 55.7 (12.2) Male (%) 141 (44.1) 142 (45.2) 146 (47.2) White (%) 284 (88.8) 278 (88.5) 276 (89.3) Hispanic or L
Slide 10: Safety
Safety Resmetirom Resmetirom Placebo 80 mg 100 mg Safety population (N=327) (N=324) (N=318) At least one TEAE 289 (88.4) 279 (86.1) 260 (81.8) At least one Serious TEAE 20 (6.1) 24 (7.4) 20 (6.3) TEAE ≥ Grade 3 Severity 26 (8.0) 29 (9.0) 29 (9.1) AE discontinuations from study All treatments combine
Slide 11: Key Secondary Endpoints (mITT)
Key Secondary Endpoints (mITT) Resmetirom Resmetirom p-value Resmetirom p-value Placebo 100 mg OL 80 mg 100 mg LDLc %CFB (SE) (Week 24) -21 (1.9) -12.7 (2.1) <.0001 -14.4 (2.1) <.0001 -1.7 (2.0) ApoB %CFB (SE) (Week 24) -22 (1.5) -14.6 (1.5) <.0001 -16.6 (1.6) <.0001 -0.1 (1.5) MRI-PDFF %CFB (Week 1
Slide 12: Safety database
Safety database ◼ Based on patients dosed with at least 100 and/or 80 mg per day in completed and ongoing studies, resmetirom has dosed a number of subjects in relevant studies that we believe is consistent with ICH guidance for safety database for long-term treatment therapies (at least 1500 patien
Slide 13: Conclusions
Conclusions ◼ Resmetirom was safe and well-tolerated at the top dose of 100 mg in MAESTRO-NAFLD-1 ◼ Key secondary endpoints were achieved in MAESTRO-NAFLD-1 ◼ Safety and efficacy are in line with expectations from Phase 2 liver biopsy study and randomized parallel open label 100 mg arm of MAESTRO-NA
Slide 14: Q&A
Q&A January 22 Madrigal Pharmaceuticals 14
Slide 15: Thank You
Thank You January 22 Madrigal Pharmaceuticals 15
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