claseprubart (DNTH103) / Dianthus Therap, Zenas BioPharma - LARVOL DELTA

A Phase 1, Placebo-Controlled, Single/Multiple Ascending Dose Study of DNTH103 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Intravenous and Subcutaneous Administration in Healthy Volunteers. (ANZCTR) - P1 | N=96 | Completed | Sponsor: Dianthus Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion

A Phase 1, Placebo-Controlled, Single/Multiple Ascending Dose Study of DNTH103 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Intravenous and Subcutaneous Administration in Healthy Volunteers. (Part C) (ANZCTR) - P1 | N=8 | Completed | Sponsor: Dianthus Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion

A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC) (clinicaltrials.gov) - P2 | N=65 | Active, not recruiting | Sponsor: Dianthus Therapeutics | Trial primary completion date: Dec 2025 ➔ Aug 2025 | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2027 ➔ Aug 2027

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Myasthenia Gravis

Dianthus Therapeutics Completes Enrollment of Phase 2 MaGic Trial of DNTH103 in Generalized Myasthenia Gravis With Top-Line Results Expected in September (GlobeNewswire) - "Dianthus Therapeutics...announced completion of enrollment in the Phase 2 MaGic trial of DNTH103 in patients with generalized Myasthenia Gravis (gMG)....Initial top-line results from the MaGic trial are anticipated in September 2025. MaGic is a global, randomized, double-blind, placebo-controlled Phase 2 trial that enrolled 65 patients with acetylcholine receptor (AChR) antibody positive gMG, exceeding the enrollment target of 60 patients."

Enrollment closed • P2 data • Myasthenia Gravis

Dianthus Therapeutics Highlights Recent Business Achievements and Reports Q4 and FY 2024 Financial Results (GlobeNewswire) - "Phase 2 MaGic trial of DNTH103 in generalized Myasthenia Gravis (gMG) ongoing; top-line results on track for 2H’25. Phase 3 CAPTIVATE trial of DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ongoing; interim responder analysis anticipated in 2H’26. Phase 2 MoMeNtum trial of DNTH103 in Multifocal Motor Neuropathy (MMN) ongoing; top-line results anticipated in 2H’26."

P2 data • P3 data • Immunology • Myasthenia Gravis

A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE) (clinicaltrials.gov) - P3 | N=480 | Recruiting | Sponsor: Dianthus Therapeutics

New P3 trial • Pain

MOMENTUM: A Clinical Study to Evaluate DNTH103 in Adults with Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Dianthus Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Complement-mediated Rare Disorders • Pain

MOMENTUM: A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Dianthus Therapeutics

New P2 trial • Complement-mediated Rare Disorders • Pain

Long-term safety outcomes of rozanolixizumab treatment in patients with generalised myasthenia gravis: A pooled analysis (EAN 2024) - P3 | "Incidence of TEAEs did not increase with repeated rozanolixizumab treatment cycles; repeated treatment was well tolerated with an acceptable safety profile."

Retrospective data • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Infectious Disease • Myasthenia Gravis • Pain

DNTH103, a Potentially Safer and More Convenient Novel Therapy for Generalised Myasthenia Gravis (EAN 2024) - "The ability of DNTH103 to improve neurotransmission and muscle contraction and selectively inhibit the CP makes it an attractive research candidate for gMG while potentially reducing the risk of severe infection seen with current gMG therapies."

CNS Disorders • Fatigue • Infectious Disease • Meningococcal Infections • Myasthenia Gravis

DNTH103: Preventing Nerve Damage in a CIDP Model via Sustained Complement Inhibition (EAN 2024) - "DNTH103 selectively binds to active C1s and effectively blocks complement- mediated inhibition of conduction detected in sera from CIDP patients. DNTH103 is an attractive research candidate for CIDP due to its potent activity, selectivity for active C1s, and extended circulating half- life."

Hematological Disorders • Immunology • Pain

A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC) (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Dianthus Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Myasthenia Gravis

Classical Pathway Inhibition with Anti-active C1s Antibody DNTH103 Prevents Neurotransmission Impairment in a Preclinical Model of Myasthenia Gravis (AAN 2024) - "DNTH103 improved neurotransmission impairment in a physiologically relevant preclinical MG model, providing additional scientific rationale for DNTH103 in this disease. DNTH103 is being investigated in Phase II trial in MG."

Preclinical • CNS Disorders • Fatigue • Infectious Disease • Myasthenia Gravis

A Phase 1, Placebo-Controlled, Single/Multiple Ascending Dose Study of DNTH103 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Intravenous and Subcutaneous Administration in Healthy Volunteers. (Part C) (ANZCTR) - P1 | N=8 | Recruiting | Sponsor: Dianthus Therapeutics, Inc.

New P1 trial

A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC) (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Dianthus Therapeutics

New P2 trial • CNS Disorders • Myasthenia Gravis