Dianthus Therapeutics (DNTH) Jefferies 2024 Global Healthcare Conference summary

Program updates and clinical progress

• Lead program DNTH103 targets the classical complement pathway for severe autoimmune diseases, with a focus on myasthenia gravis, CIDP, and MMN.

• Phase II trial in myasthenia gravis began in Q1, with top-line results expected in the second half of 2025.

• Phase II programs for MMN and CIDP are set to initiate soon, with updates expected later this year.

• Cash runway extends into the second half of 2027, supporting ongoing and planned trials.

• DNTH103 aims to offer best-in-class properties and commercial synergies across neuromuscular indications.

Market landscape and competitive differentiation

• Myasthenia gravis is a multi-billion dollar market dominated by IV biologics, with significant unmet needs for improved therapies.

• DNTH103 is positioned as a self-administered, subcutaneous autoinjector dosed every two weeks, offering a convenience advantage over competitors.

• Head-to-head in vitro data show DNTH103 has 4-8x higher affinity and 3-12x greater pharmacodynamic potency than Sanofi's riliprubart.

• Maintenance dosing for DNTH103 is one 2 mL injection every two weeks, compared to riliprubart's two 2 mL injections weekly.

• MMN and CIDP represent additional opportunities, with proof of concept for classical pathway inhibition validated by competitor data.

Clinical data and safety profile

• Phase I data confirm a 60-day half-life for DNTH103, supporting infrequent dosing and strong pathway inhibition.

• PK/PD modeling shows 300 mg every two weeks maintains drug levels 40% above IC90, ensuring robust efficacy.

• Safety profile is favorable, with no serious or grade 3/4 adverse events and only mild injection site reactions.

• No infections related to complement inhibition observed; two transient ANA positive cases were not clinically significant.

• Phase II study in MG is testing both 300 mg and 600 mg doses to assess efficacy and safety at higher inhibition levels.