Dianthus Therapeutics Completes Key Trial Enrollment for DNTH103
Dianthus Therapeutics Completes Enrollment of Phase 2 MaGic Trial
MaGic trial exceeded enrollment target of 60 patients
Top-line results from the trial are highly anticipated
Advancing a neuromuscular portfolio with DNTH103 and a focus on chronic autoimmune disorders
NEW YORK and WALTHAM, Mass. — Dianthus Therapeutics, Inc. (NASDAQ: DNTH), a clinical-stage biotechnology company striving to develop the next generation of antibody complement therapeutics to address severe autoimmune diseases, proudly announces the completion of patient enrollment for the Phase 2 MaGic trial of its investigational drug DNTH103 in individuals diagnosed with generalized Myasthenia Gravis (gMG). The initial top-line results from this important trial are expected in the near future.
The MaGic trial, which is a global, randomized, double-blind, placebo-controlled Phase 2 study, has successfully enrolled 65 patients, surpassing its target of 60 participants; all diagnosed with acetylcholine receptor (AChR) antibody positive gMG. The primary focus of this trial is to assess safety and tolerability, while secondary endpoints will involve evaluating the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) and Quantitative Myasthenia Gravis (QMG) score assessments.
“We are thrilled to have achieved this critical milestone in developing DNTH103 for gMG,” remarked Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “Recent research suggests that the gMG demographic in the U.S. exceeds 100,000 patients, with roughly 85% affected by AChR autoantibody-driven disease. There is a rising trend in first-line biologic applications, indicating a substantial unmet medical need for therapies that provide consistent symptom management while minimizing infection risks and enhancing ease of administration—an area where we believe DNTH103 can excel.”
DNTH103 is designed as a potent monoclonal antibody targeting the classical pathway, specifically inhibiting the active form of the C1s protein, a key player in the complement system. This innovative medication is tailored for subcutaneous administration and is meant to be self-injected once every two weeks, reinforcing its potential as a convenient first-line treatment option. Moreover, DNTH103 aims to address unmet needs across various autoimmune disorders and is currently being investigated in the ongoing Phase 3 CAPTIVATE trial for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as well as in the Phase 2 MoMeNtum trial for Multifocal Motor Neuropathy (MMN). The company is poised for an interim responder analysis of the Phase 3 CAPTIVATE trial and expects to report top-line data from the MoMeNtum trial in the latter part of 2026.
About the Phase 2 MaGic Trial
The MaGic trial represents a pivotal global investigation into the effects of DNTH103 on patients diagnosed with generalized Myasthenia Gravis who are AChR antibody positive. Following an initial loading dose, patients will receive DNTH103 via subcutaneous injection every two weeks for an initial 12-week treatment window, followed by a 52-week open-label extension. The primary outcome measure focuses on safety and tolerability, while key secondary measures will assess daily living activities and disease severity using validated scoring systems.
Understanding Generalized Myasthenia Gravis (gMG)
Generalized Myasthenia Gravis is a chronic autoimmune condition where the body’s immune system mistakenly attacks healthy muscle receptors, leading to symptoms such as severe muscle weakness. In the United States, over 100,000 individuals are affected by this condition, with a significant portion—approximately 85%—having AChR autoantibody-driven disease. While existing therapies exist, many patients still seek improved treatment options that can provide effective symptom relief with lower risks of infections and simpler administration protocols.
The Promise of DNTH103
DNTH103 stands out as an investigational monoclonal antibody developed to inhibit the classical pathway specifically by targeting active C1s proteins. The innovative formulation includes YTE half-life extension technology for enhanced convenience, allowing it to be administered as infrequently as every two weeks. This selective inhibition approach may reduce patient susceptibility to infections associated with encapsulated bacteria by maintaining the immune function of the lectin and alternative pathways. As conditions linked to classical pathway involvement represent significant challenges in treatment efficacy, DNTH103 is seen as a promising candidate for multiple autoimmune disorders.
Dianthus is steadfast in developing a comprehensive neuromuscular portfolio, with DNTH103 leading the charge. Anticipation for results from the MaGic trial is high, with top-line insights expected soon. Furthermore, plans for future analyses and updates concerning the Phase 3 CAPTIVATE trial and the Phase 2 MoMeNtum trial remain in active development.
About Dianthus Therapeutics
Dianthus Therapeutics remains committed to pioneering advancements in biopharmaceuticals by introducing innovative monoclonal antibodies with superior selectivity and effectiveness. With its headquarters located in New York City and Waltham, Massachusetts, Dianthus combines the expertise of seasoned professionals in biotechnology and pharmaceutical sectors, concentrating on the advancement of next-generation therapeutic solutions targeting severe autoimmune and inflammatory diseases.
For more information about our work, please visit www.dianthustx.com and engage with us on LinkedIn.
Frequently Asked Questions
What is the MaGic trial about?
The MaGic trial is a Phase 2 clinical study investigating DNTH103's effectiveness in treating generalized Myasthenia Gravis.
How many patients were enrolled in the trial?
The trial enrolled a total of 65 patients, exceeding the initial target of 60.
What is DNTH103?
DNTH103 is an investigational monoclonal antibody designed to inhibit the classical pathway of complement activation to potentially treat autoimmune diseases.
What are the expected outcomes of the MaGic trial?
Primary outcomes include safety and tolerability, with secondary outcomes assessing daily living activities and disease severity.
When will top-line results be available?
Top-line results from the Phase 2 MaGic trial are anticipated soon, following the completion of patient enrollment.
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