Dianthus Therapeutics Completes Enrollment of Phase 2 MaGic Trial of DNTH103 in Generalized Myasthenia Gravis With Top-Line Results Expected in September
Dianthus Therapeutics (DNTH) has completed enrollment for its Phase 2 MaGic trial of DNTH103 in generalized Myasthenia Gravis (gMG), exceeding the target with 65 patients enrolled. Top-line results are expected in September 2025. DNTH103 is a monoclonal antibody targeting the classical pathway by inhibiting the active C1s protein, designed for convenient self-administered subcutaneous injection every two weeks.
The trial focuses on patients with acetylcholine receptor antibody-positive gMG, with primary endpoints evaluating safety and tolerability. The U.S. gMG market exceeds 100,000 patients, with 85% having AChR autoantibody-driven disease. DNTH103 is also being evaluated in Phase 3 CAPTIVATE trial for CIDP and Phase 2 MoMeNtum trial for MMN, with results expected in 2H'26.
Dianthus Therapeutics (DNTH) ha completato l'arruolamento per il suo studio di Fase 2 MaGic su DNTH103 nella Miastenia Gravis generalizzata (gMG), superando l'obiettivo con 65 pazienti arruolati. I risultati principali sono attesi per settembre 2025. DNTH103 è un anticorpo monoclonale che agisce sulla via classica inibendo la proteina C1s attiva, progettato per essere somministrato comodamente tramite iniezione sottocutanea autogestita ogni due settimane.
Lo studio si concentra su pazienti con gMG positivi agli anticorpi contro il recettore dell'acetilcolina, con endpoint primari che valutano sicurezza e tollerabilità. Il mercato statunitense della gMG supera i 100.000 pazienti, di cui l'85% affetto da malattia mediata da autoanticorpi AChR. DNTH103 è inoltre in valutazione nello studio di Fase 3 CAPTIVATE per la CIDP e nello studio di Fase 2 MoMeNtum per la MMN, con risultati attesi nella seconda metà del 2026.
Dianthus Therapeutics (DNTH) ha completado el reclutamiento para su ensayo de Fase 2 MaGic de DNTH103 en Miastenia Gravis generalizada (gMG), superando la meta con 65 pacientes inscritos. Se esperan los resultados principales para septiembre de 2025. DNTH103 es un anticuerpo monoclonal que actúa sobre la vía clásica inhibiendo la proteína C1s activa, diseñado para una administración subcutánea autoadministrada cada dos semanas.
El ensayo se centra en pacientes con gMG positivos para anticuerpos contra el receptor de acetilcolina, con puntos finales primarios que evalúan la seguridad y tolerabilidad. El mercado estadounidense de gMG supera los 100,000 pacientes, con un 85% con enfermedad impulsada por autoanticuerpos AChR. DNTH103 también se está evaluando en el ensayo de Fase 3 CAPTIVATE para CIDP y en el ensayo de Fase 2 MoMeNtum para MMN, con resultados esperados en la segunda mitad de 2026.
Dianthus Therapeutics (DNTH)는 전신 중증근무력증(gMG)을 대상으로 한 DNTH103의 2상 MaGic 임상시험 등록을 완료했으며, 목표를 초과한 65명의 환자를 등록했습니다. 주요 결과는 2025년 9월에 발표될 예정입니다. DNTH103은 활성화된 C1s 단백질을 억제하여 고전 경로를 차단하는 단클론 항체로, 2주마다 자가 투여가 가능한 피하 주사 형태로 설계되었습니다.
이 임상시험은 아세틸콜린 수용체 항체 양성 gMG 환자를 대상으로 하며, 주요 평가 항목은 안전성과 내약성입니다. 미국의 gMG 시장은 10만 명 이상이며, 이 중 85%가 AChR 자가항체에 의해 유발된 질환입니다. DNTH103은 또한 CIDP를 위한 3상 CAPTIVATE 시험과 MMN을 위한 2상 MoMeNtum 시험에서도 평가 중이며, 결과는 2026년 하반기에 기대됩니다.
Dianthus Therapeutics (DNTH) a terminé le recrutement pour son essai de phase 2 MaGic de DNTH103 dans la myasthénie grave généralisée (gMG), dépassant l'objectif avec 65 patients inclus. Les résultats principaux sont attendus pour septembre 2025. DNTH103 est un anticorps monoclonal ciblant la voie classique en inhibant la protéine C1s active, conçu pour une injection sous-cutanée autoadministrée toutes les deux semaines.
L'essai porte sur des patients atteints de gMG positifs aux anticorps du récepteur de l'acétylcholine, avec des critères d'évaluation principaux portant sur la sécurité et la tolérance. Le marché américain de la gMG dépasse les 100 000 patients, dont 85 % présentent une maladie liée aux auto-anticorps AChR. DNTH103 est également évalué dans l'essai de phase 3 CAPTIVATE pour la CIDP et dans l'essai de phase 2 MoMeNtum pour la MMN, avec des résultats attendus au second semestre 2026.
Dianthus Therapeutics (DNTH) hat die Rekrutierung für seine Phase-2-Studie MaGic zu DNTH103 bei generalisierter Myasthenia Gravis (gMG) abgeschlossen und das Ziel mit 65 eingeschlossenen Patienten übertroffen. Die wichtigsten Ergebnisse werden für September 2025 erwartet. DNTH103 ist ein monoklonaler Antikörper, der den klassischen Weg durch Hemmung des aktiven C1s-Proteins blockiert und für eine bequeme, alle zwei Wochen selbst verabreichte subkutane Injektion entwickelt wurde.
Die Studie konzentriert sich auf Patienten mit acetylcholinrezeptor-positiver gMG, wobei die primären Endpunkte Sicherheit und Verträglichkeit bewerten. Der US-amerikanische gMG-Markt umfasst über 100.000 Patienten, von denen 85 % an einer durch AChR-Autoantikörper verursachten Erkrankung leiden. DNTH103 wird außerdem in der Phase-3-Studie CAPTIVATE für CIDP und der Phase-2-Studie MoMeNtum für MMN geprüft, mit Ergebnissen, die in der zweiten Hälfte des Jahres 2026 erwartet werden.
- Trial exceeded enrollment target with 65 patients vs planned 60
- Large market opportunity with over 100,000 gMG patients in the U.S.
- Potential for more convenient dosing with self-administered injection every two weeks
- Multiple catalysts expected: gMG results in September 2025 and two additional trial results in 2H'26
- Still in early Phase 2 stage with no efficacy data yet
- Will face competition from existing approved treatments in the market
Insights
Dianthus reaches clinical milestone with completed gMG trial enrollment; potential differentiation in convenience if September data positive.
Dianthus Therapeutics has successfully completed enrollment for its Phase 2 MaGic trial of DNTH103 in generalized Myasthenia Gravis (gMG), exceeding the target with 65 patients enrolled versus the planned 60. This execution efficiency is a positive operational sign, with topline data expected in September 2025.
The market opportunity is substantial, with over 100,000 gMG patients in the US alone, approximately 85% with AChR autoantibody-driven disease. This represents Dianthus's first of three anticipated data catalysts, with additional readouts from trials in CIDP and MMN expected by year-end 2026.
DNTH103's potential differentiation centers on its selective inhibition of only the active form of C1s protein in the classical complement pathway, potentially enabling a more targeted approach than broader complement inhibitors. The subcutaneous self-administered autoinjector dosed every two weeks could offer meaningful convenience advantages if efficacy proves comparable to existing options.
This milestone keeps Dianthus on track with its stated clinical development timeline across three neuromuscular indications. The company's strategic focus on building a neuromuscular franchise with a single molecule demonstrates pipeline efficiency, though commercial potential remains contingent on forthcoming efficacy and safety data.
Selective C1s inhibition offers intriguing mechanistic approach for gMG; convenience factors could address adherence challenges if efficacy demonstrated.
Generalized Myasthenia Gravis represents a significant clinical challenge with its fluctuating muscle weakness affecting activities of daily living. The MaGic trial's focus on AChR antibody-positive patients (85% of gMG cases) appropriately targets the largest patient segment where complement activation is a well-established disease mechanism.
The study's secondary endpoints using the MG-ADL and QMG scales are appropriate validated measures that assess both patient-reported outcomes and objective strength testing, providing complementary efficacy assessments. These are standard endpoints used across gMG clinical trials.
DNTH103's selective inhibition of the classical complement pathway through C1s represents a targeted approach to interrupt the autoimmune cascade in gMG without affecting alternative and lectin complement pathways important for certain infections. This selectivity could potentially maintain some protective immune functions while blocking disease-driving processes.
The less frequent dosing (every two weeks) and subcutaneous administration could significantly improve treatment adherence compared to more frequently dosed therapies or those requiring infusions. For patients with limb weakness, self-administration options can be particularly valuable. However, the actual clinical benefits remain to be demonstrated in the upcoming data readout.
MaGic trial exceeded enrollment target of 60 patients
Top-line results anticipated this September will be the first of three DNTH103 catalysts by YE'26
Building a neuromuscular franchise with DNTH103 in gMG, CIDP and MMN with a potential best-in-class, potent classical pathway inhibitor intended as a self-administered autoinjector dosed once every two weeks
NEW YORK and WALTHAM, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today announced completion of enrollment in the Phase 2 MaGic trial of DNTH103 in patients with generalized Myasthenia Gravis (gMG). DNTH103 is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein. 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. The primary endpoint of the trial is safety and tolerability, and key secondary endpoints include Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) and Quantitative Myasthenia Gravis (QMG) score assessments.
“We are pleased to have reached this important milestone in the development of DNTH103 for gMG, which is well understood to be a classical pathway-driven disease,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “Latest estimates indicate that the gMG market in the U.S. exceeds 100,000 patients, approximately
DNTH103 is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. DNTH103 is designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need and is also being evaluated in the ongoing Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and the ongoing Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy (MMN). The Company is on track for the interim responder analysis of the Phase 3 CAPTIVATE trial in CIDP and top-line data from the Phase 2 MoMeNtum trial in MMN in 2H’26.
About the Phase 2 MaGic Trial
The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 study in patients with generalized Myasthenia Gravis who are acetylcholine receptor (AChR) antibody positive. Following an initial loading dose, DNTH103 will be administered every two weeks (Q2W) via subcutaneous (S.C.) injection. The S.C. treatment duration will initially be 12 weeks with a 52-week open-label extension. The primary endpoint of the study is safety and tolerability. Secondary endpoints include Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) and Quantitative Myasthenia Gravis (QMG) score assessments. Initial top-line results from this trial are anticipated in September 2025.
About Generalized Myasthenia Gravis (gMG)
Generalized Myasthenia Gravis (gMG) is a chronic autoimmune disorder driven by the classical pathway that causes progressive muscle weakness. Over 100,000 people in the U.S. are living with gMG and approximately
About DNTH103
DNTH103 is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. DNTH103 is enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. As the classical pathway plays a significant role in disease pathology, DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Dianthus is building a neuromuscular franchise with DNTH103 and anticipates reporting top-line data from the Phase 2 MaGic trial in generalized Myasthenia Gravis in September 2025, the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy in 2H’26, and top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in 2H’26.
DNTH103 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide.
About Dianthus Therapeutics
Dianthus Therapeutics is a clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases.
To learn more, please visit www.dianthustx.com and follow us on LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995, express or implied statements regarding future plans and prospects, including statements regarding the expectations or plans for discovery, preclinical studies, clinical trials and research and development programs, in particular with respect to DNTH103, and any developments or results in connection therewith, including the target product profile and administration of DNTH103; the anticipated timing of the initiation and results from those studies and trials; expectations regarding the time period over which the Company’s capital resources are expected to be sufficient to fund its anticipated operations; and expectations regarding the market and potential opportunities for complement therapies, in particular with respect to DNTH103. The words “opportunity,” “potential,” “milestones,” “runway,” “will,” “anticipate,” “achieve,” “near-term,” “catalysts,” “pursue,” “pipeline,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions (including the negatives of these terms or variations of them) generally identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking.
Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that preclinical testing of DNTH103 and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the development of DNTH103 or the Company's other compounds may take longer and/or cost more than planned, that the Company may be unable to successfully complete the clinical development of the Company’s compounds, that the Company may be delayed in initiating, enrolling or completing its planned clinical trials, and that the Company's compounds may not receive regulatory approval or become commercially successful products. These and other risks and uncertainties are identified under the heading "Risk Factors" included in the Company’s Annual Report on Form 10-K for the period ended December 31, 2024, and other filings that the Company has made and may make with the SEC in the future. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.
The forward-looking statements in this press release speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Dianthus undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
Contact
Jennifer Davis Ruff
Dianthus Therapeutics
jdavisruff@dianthustx.com
FAQ
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