Dianthus Therapeutics Highlights New Claseprubart Data Presented During 2025 AANEM Annual Meeting
Dianthus Therapeutics (Nasdaq: DNTH) presented new Phase 2 MaGic and preclinical data for claseprubart at the AANEM Annual Meeting and a virtual industry forum on Oct 29, 2025. Key clinical findings include an open-label extension (OLE) MG-ADL decline of -2.5 points at week 4 and a QMG reduction of -3.2 points for placebo-arm patients who received two 600mg/4mL Q2W doses. A post hoc subgroup with baseline QMG ≥10 showed a 3-point MG-ADL treatment difference for 300mg/2mL Q2W versus placebo. In vitro data suggested upstream (active C1s) inhibition may better prevent pro-inflammatory split products C3a/C3b versus C5 inhibition. Dianthus plans a Phase 3 gMG trial with two claseprubart arms (300mg/2mL Q2W and 300mg/2mL Q4W) versus placebo, anticipated to initiate in 2026.
Dianthus Therapeutics (Nasdaq: DNTH) ha presentato nuovi dati di fase 2 MaGic e preclinici su claseprubart durante la riunione annuale AANEM e un forum virtuale del settore il 29 ottobre 2025. I principali risultati clinici includono una estensione in etichetta aperta (OLE) MG-ADL in calo di -2.5 punti alla settimana 4 e una riduzione di QMG di -3.2 punti nei pazienti del braccio placebo che hanno ricevuto due dosi da 600 mg/4 mL ogni due settimane. Un sottogruppo post-hoc con QMG basale ≥10 ha mostrato una differenza di trattamento MG-ADL di 3 punti per 300 mg/2 mL Q2W rispetto al placebo. I dati in vitro suggeriscono che l'inibizione a monte (C1s attivo) potrebbe prevenire meglio i prodotti di scissione pro-infiammatori C3a/C3b rispetto all'inibizione di C5. Dianthus prevede uno studio di fase 3 gMG con due bracci di claseprubart (300 mg/2 mL Q2W e 300 mg/2 mL Q4W) contro placebo, previsto per l'inizio nel 2026.
Dianthus Therapeutics (Nasdaq: DNTH) presentó nuevos datos de Fase 2 MaGic y preclínicos sobre claseprubart en la Reunión Anual de AANEM y un foro virtual de la industria el 29 de octubre de 2025. Los hallazgos clínicos clave incluyen una extensión en etiqueta abierta (OLE) de MG-ADL que cayó -2.5 puntos en la semana 4 y una reducción de QMG de -3.2 puntos para pacientes del brazo placebo que recibieron dos dosis de 600 mg/4 mL cada dos semanas. Un subgrupo post-hoc con QMG basal ≥10 mostró una diferencia de tratamiento MG-ADL de 3 puntos para 300 mg/2 mL Q2W frente a placebo. Datos in vitro sugieren que la inhibición aguas arriba (C1s activo) podría prevenir mejor los productos de escisión proinflamatorios C3a/C3b frente a la inhibición de C5. Dianthus planea un ensayo de fase 3 gMG con dos brazos de claseprubart (300 mg/2 mL Q2W y 300 mg/2 mL Q4W) frente a placebo, previsto para iniciar en 2026.
Dianthus Therapeutics (Nasdaq: DNTH)는 2025년 10월 29일 AANEM 연례회의 및 가상 업계 포럼에서 claseprubart에 대한 새로운 2상 MaGic 및 전임상 데이터를 발표했습니다. 주요 임상 발견으로는 4주 차에 오픈 레이블 확장(OLE) MG-ADL이 -2.5점 감소했고, 위약군이 두 번의 600mg/4mL Q2W 투여를 받은 경우 QMG가 -3.2점 감소했습니다. 기저 QMG가 ≥10인 사후 분석 하위그룹은 300mg/2mL Q2W가 위약 대비 MG-ADL에서 3점 차이를 보였습니다. 체외(in vitro) 데이터는 활성 C1s를 표적한 상류 억제가 C3a/C3b의 친염성 분해 산물을 더 잘 방지할 수 있음을 시사했습니다. Dianthus는 2026년에 시작될 것으로 예상되는 두 개의 claseprubart 군(300mg/2mL Q2W 및 300mg/2mL Q4W) 대비 위약의 3상 gMG 시험을 계획하고 있습니다.
Dianthus Therapeutics (Nasdaq: DNTH) a présenté de nouvelles données de phase 2 MaGic et des données précliniques sur le claseprubart lors de la réunion annuelle de l'AANEM et d'un forum virtuel de l'industrie le 29 octobre 2025. Parmi les résultats cliniques clés figurent une extension en étiquette ouverte (OLE) MG-ADL en baisse de -2,5 points à la semaine 4 et une réduction de QMG de -3,2 points chez les patients du bras placebo ayant reçu deux doses de 600 mg/4 mL toutes les deux semaines. Un sous-groupe post-hoc dont le QMG de base est ≥10 a montré une différence de traitement MG-ADL de 3 points pour 300 mg/2 mL Q2W versus placebo. Des données in vitro suggèrent qu'une inhibition en amont (C1s actif) pourrait mieux prévenir les produits de dissociation pro-inflammatoires C3a/C3b par rapport à l'inhibition de C5. Dianthus prévoit un essai de phase 3 gMG avec deux bras de claseprubart (300 mg/2 mL Q2W et 300 mg/2 mL Q4W) contre placebo, prévu pour démarrer en 2026.
Dianthus Therapeutics (Nasdaq: DNTH) präsentierte neue Phase-2-Daten zu MaGic und präklinische Daten zu claseprubart auf der AANEM-Jahrestagung und einem virtuellen Branchenforum am 29. Oktober 2025. Zu den wichtigsten klinischen Ergebnissen gehören eine offene Etappenverlängerung (OLE) MG-ADL um -2,5 Punkte in Woche 4 und eine QMG-Reduktion um -3,2 Punkte bei Placebo-Teilnehmern, die zwei Dosen von 600 mg/4 mL alle zwei Wochen erhielten. Eine post-hoc-Untergruppe mit Baseline QMG ≥10 zeigte eine MG-ADL-Behandlungslücke von 3 Punkten für 300 mg/2 mL Q2W gegenüber Placebo. In-vitro-Daten deuten darauf hin, dass eine Upstream-Hemmung (aktives C1s) besser verhindern könnte proinflammatorische Spaltungsprodukte C3a/C3b als C5-Hemmung. Dianthus plant eine Phase-3-GMG-Studie mit zwei Claseprubart-Armen (300 mg/2 mL Q2W und 300 mg/2 mL Q4W) gegenüber Placebo, voraussichtlich 2026 beginnen.
Dianthus Therapeutics (Nasdaq: DNTH) قدمت بيانات جديدة من المرحلة 2 MaGic وبيانات قبل السريرية عن claseprubart في الاجتماع السنوي لـ AANEM ومنتدى صناعي افتراضي في 29 أكتوبر 2025. تتضمن النتائج السريرية الأساسية انخفاض MG-ADL في التمديد مفتوح (OLE) بمقدار -2.5 نقاط في الأسبوع 4 وانخفاض QMG بمقدار -3.2 نقاط للمرضى في ذراع الدواء الوهمي الذين تلقوا جرعتين من 600mg/4mL كل أسبوعين. أظهر فريق فرعي لاحق بناءً على QMG الأساسي ≥10 فرق علاج MG-ADL قدره 3 نقاط لـ 300mg/2mL Q2W مقابل الدواء الوهمي. أشارت بيانات في المختبر إلى أن تثبيط الفرد الأعلى (C1s النشط) قد يمنع بشكل أفضل المنتجات الانشقاقية المبرزة للالتهاب C3a/C3b مقارنة بتثبيط C5. تخطط Dianthus لإجراء تجربة المرحلة 3 gMG بذرعَين من claseprubart (300mg/2mL Q2W و300mg/2mL Q4W) مقابل الدواء الوهمي، من المتوقع بدايتها في 2026.
Dianthus Therapeutics（纳斯达克股票代码：DNTH）在 2025 年 10 月 29 日的 AANEM 年会和一个虚拟行业论坛上，公布了关于 claseprubart 的新一轮 2 期 MaGic 数据及前临床数据。关键临床发现包括开放标签扩展（OLE）中 MG-ADL 在第 4 周下降了 -2.5 点，以及安慰剂组在接受两次 600 mg/4 mL、每两周一次治疗后 QMG 下降了 -3.2 点。基线 QMG ≥10 的事后亚组显示，300 mg/2 mL Q2W 相对于安慰剂在 MG-ADL 的治疗差异为 3 点。体外数据提示，上游抑制（活性 C1s）可能比 C5 抑制更能预防促炎性分解产物 C3a/C3b。Dianthus 计划开展两臂 claseprubart 的 3 期 gMG 试验（300 mg/2 mL Q2W 和 300 mg/2 mL Q4W）对照安慰剂，预计将于 2026 年启动。
- MG-ADL -2.5 at week 4 in the OLE
- QMG -3.2 reduction in OLE for prior placebo patients after two 600mg doses
- 3-point MG-ADL treatment difference for 300mg/2mL Q2W in QMG ≥10 subgroup
- Phase 3 gMG trial planned with two active arms plus placebo, anticipated 2026
- In vitro data: upstream C1s inhibition reduced C3a/C3b formation vs C5
- Key subgroup result is a post hoc analysis, which is hypothesis-generating not definitive
- Two-dose 600mg/4mL Q2W exposure produced PK far below steady state, indicating dosing uncertainties
Positive data from Phase 2 MaGic trial presented for claseprubart in generalized Myasthenia Gravis, including new open-label extension data further supporting potential for 300mg/2mL Q4W dosing
Phase 3 gMG trial planned to include QMG ≥10 screening criteria and two claseprubart treatment arms, 300mg/2mL Q2W and 300mg/2mL Q4W, vs. placebo anticipated to initiate in 2026
Additionally, new preclinical data highlight potential efficacy benefits of upstream (aC1s) vs. downstream (C5) complement inhibition
Virtual industry forum replay available
NEW YORK and WALTHAM, Mass., Oct. 29, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today reviewed new data from the Phase 2 MaGic trial of claseprubart in generalized Myasthenia Gravis (gMG) presented during the Myasthenia Gravis Foundation of America (MGFA) Scientific Session of the American Association of Neuromuscular and Electromagnetic Medicine (AANEM) Annual Meeting.
During AANEM, Dr. Pushpa Narayanaswami, MD from Harvard Medical School presented the successful Phase 2 MaGic trial data for the first time at a medical conference. In addition, during a Virtual Industry Forum titled Upstream Targeting: Rethinking MG Treatment Through Active C1s Inhibition, new data were released, which included:
- A robust MG-ADL decline at week 4 in the open-label extension (OLE) of -2.5 points and QMG score reduction of -3.2 points for patients on placebo during the RCT who received only two doses of claseprubart 600mg/4mL Q2W without a loading dose and achieved a PK level far below the steady state of 300mg/2mL Q2W, supporting potential for Q4W dosing of 300mg/2mL
- A subgroup analysis of patients enrolled in the MaGic trial with a QMG score ≥10 at baseline which demonstrated an increase in MG-ADL treatment effect for 300mg/2mL Q2W to a 3-point difference from placebo
- In vitro data demonstrating the benefits of upstream (active C1s with claseprubart) vs. downstream (C5 with ravulizumab) inhibition in the prevention of pro-inflammatory split products C3a and C3b
“This post hoc analysis is driving our decision to add a QMG inclusion criteria and a 300mg/2mL S.C. Q4W arm, in addition to a Q2W arm, in our Phase 3 MG study,” said Simrat Randhawa, MD, MBA, Executive Vice President and Head of R&D of Dianthus Therapeutics. “Given the impressive Phase 2 data combined with the very encouraging post hoc data presented today, we are further motivated to rapidly proceed to Phase 3.”
The claseprubart data presented at AANEM and an archived webcast of the virtual industry forum titled Upstream Targeting: Rethinking MG Treatment Through Active C1s Inhibition, featuring an expert panel including Pushpa Narayanaswami, MD, Tuan Vu, MD, Stojan Peric, MD, PhD, Shahar Shelly, MD, are now available on the Dianthus Therapeutics website.
Agenda: Upstream Targeting: Rethinking MG Treatment Through Active C1s Inhibition
- Opening Remarks – Introduction to Dianthus Therapeutics and Claseprubart: Simrat Randhawa, MD, EVP and Head of R&D of Dianthus Therapeutics
- Clinical & Treatment Gaps: Tuan Vu, MD
- Panel Discussion Part 1: Clinical and Treatment Gaps
- C1s Inhibition Mechanism of Action (MoA) Animation
- Upstream Inhibition of Classical Pathway: Shahar Shelly, MD
- MaGic Phase 2 Data: Pushpa Narayanaswami, MD
- Panel Discussion Part 2: Feedback on MaGic Results and Potential of C1s Inhibition
- Closing Remarks – Phase 3 and Future Outlook: Simrat Randhawa, MD, EVP and Head of R&D of Dianthus Therapeutics
About Claseprubart (DNTH103)
Claseprubart 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. Claseprubart is enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, infrequently dosed, self-administered injection. 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, claseprubart 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 claseprubart and expects to initiate a Phase 3 trial in gMG in 2026, 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.
Claseprubart is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide.
About Dianthus Therapeutics
Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who aim 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 claseprubart, and any developments or results in connection therewith, including the target product profile and administration of claseprubart; the anticipated timing of the initiation and results from those studies and trials; expectations regarding the clinical trial design for the Phase 3 trial for claseprubart in gMG; 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 market size, patient population size, and potential opportunities for complement therapies, in particular with respect to claseprubart. Claseprubart is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. 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 claseprubart and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the development of claseprubart 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
What Phase 2 claseprubart results did Dianthus report on Oct 29, 2025 (DNTH)?
How did the QMG ≥10 subgroup perform for claseprubart in the MaGic trial (DNTH)?
What Phase 3 design did Dianthus announce for claseprubart (DNTH) and when will it start?
What did preclinical data presented by Dianthus show about upstream vs downstream complement inhibition (DNTH)?
Does the new data support Q4W dosing of claseprubart for the Phase 3 trial (DNTH)?
