Dianthus Therapeutics (NasdaqCM:DNTH) Conference Transcript

Dianthus Therapeutics Conference Summary Company Overview - Company: Dianthus Therapeutics (NasdaqCM:DNTH) - Event: First annual I&I Summit - Date: November 12, 2025 Key Points Product Development and Trials - Claseprubart: The company is preparing for the Phase 3 trial design for claseprubart, following positive results from the Phase 2 MAGIC study [5][6] - FDA Interaction: Dianthus has not yet discussed the Phase 3 trial changes with the FDA but plans to meet to discuss the addition of a Q4 week dosing arm alongside the Q2 week arm [6][8] - Dosing Strategy: The company is focusing on a dosing strategy of 300 mg every two weeks and is considering once-a-month dosing based on data consistency from various studies [9][39] Screening Criteria - QMG Score: The company is debating the inclusion of a QMG score screening criterion for the Phase 3 trial, noting that previous trials did not use such criteria and that it could complicate patient recruitment [10][11] - Baseline Characteristics: The baseline QMG scores in their trial were lower than historical data, which may indicate that the efficacy results are even more impressive given the milder patient population [12][15] Autoantibody Positivity and Safety - ANA Signal: The company reported that the ANA signal observed in the MAGIC study does not correlate with clinical symptoms, and they plan to limit ANA testing in future trials to only symptomatic patients [16][19] - Drug-Induced Lupus: There is no evidence that the drug causes drug-induced lupus, and the company plans to follow a similar approach to other successful trials by limiting unnecessary testing [17][20] Recruitment and Trial Design - Captivate Trial: The Captivate trial is enrolling faster than expected, with interim data anticipated in Q2. The design allows for a more attractive patient experience compared to competitors [22][26] - Patient Recruitment: The company believes that the design of their trials, which allows for immediate drug administration and less frequent visits, makes it more appealing for patients and investigators [23][25] Future Plans - Momentum MMN Study: The Phase 2 study is expected to report top-line results in the second half of the year, with a focus on safety and efficacy compared to existing treatments [40][41] - Auto Injector Development: Dianthus is working on a subcutaneous auto-injector strategy, aiming for a label similar to Dupixent, which would allow for easier patient administration [42][44] Competitive Landscape - Differentiation: The company aims to differentiate itself from competitors by offering a more potent classical pathway inhibitor and a more patient-friendly trial design [41][39] Additional Insights - Market Positioning: The company is positioning itself strongly in the market by focusing on patient-centric trial designs and effective dosing strategies, which could enhance its competitive edge in the therapeutic landscape [39][26] - Regulatory Strategy: The company is confident in its regulatory strategy, leveraging existing successful auto-injector designs to streamline the approval process [44][45]