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

MOMENTUM: A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=46 | Active, not recruiting | Sponsor: Dianthus Therapeutics | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2026 ➔ Dec 2026

Enrollment closed • Trial primary completion date • Complement-mediated Rare Disorders

A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE) (clinicaltrials.gov) - P3 | N=195 | Recruiting | Sponsor: Dianthus Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Myasthenia Gravis

Minimal Symptom Expression With Claseprubart, an Active C1S Inhibitor, in Patients With Generalized Myasthenia Gravis (ICNMD 2026) - P2 | "Claseprubart patients were more than four times more likely to achieve MSE than placebo patients and MSE was observed as early as Week 1. Patients who achieved MSE maintained responses for at least 6 weeks. These results highlight the therapeutic potential of aC1s inhibition in AChR+ gMG."

Clinical • CNS Disorders • Myasthenia Gravis

Multiple Responder Analyses With Claseprubart, an Active C1s Inhibitor, in Patients With Generalized Myasthenia Gravis (ICNMD 2026) - P2 | "Claseprubart-treated patients were more likely to achieve multi-dimensional response than placebo. Responses emerged early and were sustained, confirming rapid, robust, and durable benefit from claseprubart across functional and quantitative measures from both patient and clinician perspectives."

Clinical • CNS Disorders • Myasthenia Gravis

Potential Mechanistic Advantages of aC1s Targeting in Myasthenia Gravis: Upstream Versus Downstream Complement Blockade (ICNMD 2026) - "We determined whether active C1s (aC1s) inhibition by claseprubart (DNTH103) suppresses generation of C3a, C3b and MAC in comparison with C5 inhibitor ravulizumab. MAC formation was quantified using the Wieslab® Complement Classical Pathway assay in 1% normal human serum (NHS). Upstream aC1s inhibition with claseprubart prevented MAC formation and reduced C3a and C3b levels, demonstrating broader inflammatory control beyond C5 blockade. Thus upstream inhibition may provide both pathological and immunological advantages."

CNS Disorders • Myasthenia Gravis

CAPTIVATE Trial Design: A Pivotal Phase 3 Study of Claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (ICNMD 2026) - P3 | "CAPTIVATE is an innovative, rigorous Phase 3 study evaluating claseprubart, an active C1s inhibitor administered as a convenient biweekly injection, in CIDP. The design prioritizes patient safety, avoids complete washout of SOC, minimizes exposure to ineffective therapy, and provides continued access as part of an optional open-label extension."

P3 data

Safety and Efficacy of Claseprubart, an Active C1s Inhibitor, in Patients with Generalized Myasthenia Gravis (ICNMD 2026) - P2 | "With a favorable safety profile, claseprubart demonstrated rapid, statistically significant, and clinically meaningful improvements in MG-ADL, QMG, MGC."

Clinical • CNS Disorders • Immunology • Infectious Disease • Myasthenia Gravis

Minimal Symptom Expression with Claseprubart, an Active C1S Inhibitor, in Patients with Generalized Myasthenia Gravis (EAN 2026) - P2 | "Claseprubart patients were more than four times more likely to achieve MSE than placebo patients and MSE was observed as early as week 1. Patients who achieved MSE maintained responses for at least 6 weeks. These results highlight the therapeutic potential of aC1s inhibition in AChR+ gMG."

Clinical • CNS Disorders • Myasthenia Gravis

Safety and Efficacy of Claseprubart, an Active C1s Inhibitor, in Patients with Generalized Myasthenia Gravis (EAN 2026) - P2 | "With a favorable safety profile, claseprubart demonstrated rapid, statistically significant, and clinically meaningful improvements in MG-ADL, QMG, MGC."

Clinical • CNS Disorders • Immunology • Infectious Disease • Myasthenia Gravis

Multiple Responder Analyses with Claseprubart, an Active C1s Inhibitor, in Patients with Generalized Myasthenia Gravis (EAN 2026) - P2 | "Claseprubart-treated patients were more likely to achieve multi-dimensional response than placebo. Responses emerged early and were sustained, confirming rapid, robust, and durable benefit from claseprubart across functional and quantitative measures from both patient and clinician perspectives."

Clinical • CNS Disorders • Myasthenia Gravis

CAPTIVATE Trial Design: A Pivotal Phase 3 Study of Claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (EAN 2026) - No abstract available

P3 data

Dianthus Therapeutics Announces Initiation of Phase 3 Emerge Trial of Claseprubart in Generalized Myasthenia Gravis (GlobeNewswire) - "EMERGE is a global, randomized, multicenter, placebo-controlled Phase 3 trial in approximately 195 participants with generalized Myasthenia Gravis who are acetylcholine receptor antibody positive (AChR+)....The primary endpoint of this trial is the change from baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) in the treatment arms vs. the placebo arm....Top-line results from this trial are anticipated to be available in 2H’28."

P3 data: top line • Trial status • Immunology • Myasthenia Gravis

A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE) (clinicaltrials.gov) - P3 | N=195 | Not yet recruiting | Sponsor: Dianthus Therapeutics

New P3 trial • CNS Disorders • Myasthenia Gravis

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 completion date: Aug 2027 ➔ Oct 2028

Trial completion date • CNS Disorders • Myasthenia Gravis

Top-line Results From MaGic, a Phase Two Trial of Claseprubart (DNTH103), an Active C1s Inhibitor, in Generalized Myasthenia Gravis (AAN 2026) - P2 | "Conclusions With a favorable safety profile, claseprubart demonstrated rapid, statistically significant, and clinically meaningful improvements in MG-ADL, QMG, MGC. Phase 3 study in gMG is in planning."

CNS Disorders • Immunology • Infectious Disease • Myasthenia Gravis

Proximal Complement Inhibition in Generalized Myasthenia Gravis (AAN 2026) - "Objective To determine whether active C1s (aC1s) inhibition by claseprubart (DNTH103) suppresses generation of C3a, C3b and membrane attack complex (MAC), and whether its complement inhibition profile is different to that of the C5 inhibitor ravulizumab. Conclusions Upstream aC1s inhibition with claseprubart prevented MAC formation and reduced C3a and C3b to minimal levels, demonstrating potentially broader inflammatory control than C5 blockade and supporting the possibility for added clinical benefit while sparing the alternative and lectin pathways. These effects may provide immunological advantages by preserving innate defense mechanisms and pathophysiological advantages by limiting complement mediated injury at the neuromuscular junction."

Antibody-mediated Rejection • CNS Disorders • Myasthenia Gravis

A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE) (clinicaltrials.gov) - P3 | N=256 | Recruiting | Sponsor: Dianthus Therapeutics | N=480 ➔ 256

Enrollment change • Pain

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