Disc Medicine (IRON) 2025 Conference Transcript

Summary of Disc Medicine Conference Call Company Overview - Company: Disc Medicine - Focus: Development of treatments for diseases related to red blood cell metabolism, specifically through manipulation of iron and heme metabolism [5][6] Key Programs 1. Bidipertin - NDA Filing: Scheduled for October 2025 with expected acceptance in December 2025, leading to a PDUFA date in 2026 [5] - Patient Data: Approximately 6,000 engaged patients identified from a claims database, with a total of 14,000 diagnosed patients [8][9] - Market Strategy: MSLs (Medical Science Liaisons) are engaging with physicians to confirm patient existence and raise disease awareness [10][13] - Patient Education: Emphasis on educating patients about the new therapy post-approval, with a focus on transitioning from clinical trials to commercial therapy [19][20] 2. DISCO-974 - Indication: Targeting anemia of myelofibrosis (MF) with data cuts expected to be presented at ASH [6] - Competitive Landscape: Comparison with luspatercept, which failed in Phase 3 trials, highlighting the potential for DISCO-974 to address anemia more effectively across various patient subgroups [46][48] 3. Chronic Kidney Disease (CKD) Anemia - Phase 1b SADMAD Program: Data expected to be presented at ASN or ASH, focusing on iron mobilization and hemoglobin response [61][62] - Future Trials: Plans for a Phase 2 trial to confirm efficacy based on initial data, with a focus on identifying responding populations [63][64] Regulatory and Market Considerations - Regulatory Alignment: Confidence in the design of the Apollo confirmatory trial based on successful Phase 2 data, with a focus on minimizing placebo effects [38][41] - Market Entry Strategy: Anticipation of a gradual launch process, with emphasis on payer approval and physician engagement [22][24] - Patient Population: Targeting a significant unmet need in rare diseases, with a focus on educating both patients and physicians about new treatment options [19][57] Competitive Landscape - Comparative Analysis: Insights drawn from other rare disease launches, particularly Solano in rare obesity, and the challenges faced by luspatercept in treating anemia [33][46] - Market Size: Potential to address a population of approximately 22,000 anemic patients in the U.S. [56] Additional Insights - Patient Advocacy: Strong support from patient advocacy groups, which aids in raising awareness and sharing patient success stories [37] - Data Presentation: Upcoming data presentations at ASH are expected to provide further clarity on the efficacy and competitive positioning of DISCO-974 and other programs [56][65] This summary encapsulates the key points discussed during the conference call, highlighting the strategic direction and anticipated developments for Disc Medicine.