Ironwood Pharmaceuticals, Inc. · NASDAQ:IRWD
Ironwood Pharmaceuticals — Corporate Update (July 2020)
10 slides from Ironwood Pharmaceuticals's corporate update, Jul 21, 2020
Slide 1: IW-3718 Program Update
IW-3718 Program Update July 21, 2020
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements our plans to stop enrollment of study subjects into IW-3718-302 and conduct an early assessment of efficacy in th
Slide 3: Today's Agenda
Today’s Agenda • Forward-Looking Statements Meredith Kaya, VP Strategy, Investor Relations & Communications • Introduction Mark Mallon, Chief Executive Officer • IW-3718 Program Update Mike Shetzline, Chief Medical Officer • Closing Tom McCourt, President 3
Slide 4: Become the Leading U.S. Gastrointestinal Healthcare Company
IRONWOOD’S VISION & MISSION Become the Leading U.S. Gastrointestinal Healthcare Company We are dedicated to advancing the treatment of GI diseases and redefining the standard of care for millions of GI patients 4
Slide 5: Phase III Program Updates
IW-3718 Phase III Program Updates Change to Primary Endpoint Early Assessment of IW-3718-302 Long-Term Safety Data 5
Slide 6: IW-3718 Pivotal Phase 3 Program Design
IW-3718 Pivotal Phase 3 Program Design Placebo IW-3718 + PPI (BID) 1500 mg + PPI (BID) 8 WEEK TREATMENT PERIOD Patients Endpoints • Two identical, randomized, double-blind, placebo- • Change in weekly heartburn severity – New Primary (prior secondary) controlled, multicenter trials of IW-3718 • Chan
Slide 7: Primary Endpoint Changed from Responder to Continuous Endpoint
Primary Endpoint Changed from Responder to Continuous Endpoint New primary endpoint maintains high powering of Phase III trials Previous Endpoints New Endpoints Primary Endpoint Primary Endpoint • Overall heartburn responder (≥45%) • Change from baseline to Week 8 in WHSS Key Secondary Endpoints Key
Slide 8: Opportunity for Evaluation of IW-3718-302; Expect to Report Outcome in 4Q 2020
Opportunity for Evaluation of IW-3718-302; Expect to Report Outcome in 4Q 2020 Opportunity to evaluate IW-3718-302 data given well-powered trial and recent FDA guidance due to COVID-19 pandemic 4Q 2020 1H 2021 Expected assessment of IW-3718-302 data by IDMC (blinded to IRWD) Meets all pre-specified
Slide 9: Discussing Potential IW-3718 Long-term Safety Data
Discussing Potential IW-3718 Long-term Safety Data • FDA requested additional IW-3718 long-term safety data in rGERD patients in connection with an NDA submission – Ironwood provided a detailed overview of the existing long-term safety data package for colesevelam – the active ingredient in IW-3718
Slide 10: IW-3718 Presents Significant Opportunity to Bring Relief for Millions of Adult rGERD Patients
IW-3718 Presents Significant Opportunity to Bring Relief for Millions of Adult rGERD Patients (if approved) Compelling Bile Established High Unmet Need 1st In Class MOA Acid Story GI Leadership • ~8-10M U.S. adults suffer • Bile acids play a • IW-3718 is designed to target • GI category leadership f
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