Annexon Announces Presentations on the Clinical Advancement of Tanruprubart as the First Potential Targeted Therapy for Guillain-Barré Syndrome (GBS) at the 2025 PNS Meeting
Annexon (NASDAQ: ANNX) announced upcoming presentations at the 2025 Peripheral Nerve Society Annual Meeting highlighting improved outcomes with tanruprubart (formerly ANX005) for treating Guillain-Barré Syndrome (GBS). The presentations, scheduled for May 17-20, 2025 in Edinburgh, UK, will showcase comparative effectiveness data and new analyses from Phase 3 trials.
GBS is a rare autoimmune disease causing rapid weakness and potential paralysis, with no current FDA-approved treatments. Tanruprubart, a first-in-kind monoclonal antibody, targets C1q to block classical complement cascade initiation. The drug aims to halt neuroinflammation and nerve damage during acute GBS phase with a single infusion.
The presentations will include real-world evidence comparing tanruprubart to standard treatments, data linking early complement inhibition to long-term outcomes, quality of life improvements, and efficacy across a broad patient spectrum.
Annexon (NASDAQ: ANNX) ha annunciato le prossime presentazioni al Congresso Annuale della Peripheral Nerve Society 2025, in cui verranno evidenziati i miglioramenti ottenuti con tanruprubart (precedentemente ANX005) nel trattamento della Sindrome di Guillain-Barré (GBS). Le presentazioni, previste dal 17 al 20 maggio 2025 a Edimburgo, Regno Unito, presenteranno dati sull'efficacia comparativa e nuove analisi provenienti da studi di Fase 3.
La GBS è una malattia autoimmune rara che provoca debolezza rapida e possibile paralisi, senza trattamenti approvati dalla FDA attualmente disponibili. Tanruprubart, un anticorpo monoclonale innovativo, agisce contro C1q bloccando l'attivazione della cascata del complemento classico. Il farmaco mira a fermare la neuroinfiammazione e il danno ai nervi durante la fase acuta della GBS con una singola infusione.
Le presentazioni includeranno evidenze dal mondo reale che confrontano tanruprubart con i trattamenti standard, dati che collegano l'inibizione precoce del complemento agli esiti a lungo termine, miglioramenti nella qualità della vita e l'efficacia su un ampio spettro di pazienti.
Annexon (NASDAQ: ANNX) anunció próximas presentaciones en la Reunión Anual de la Peripheral Nerve Society 2025, donde se destacarán los mejores resultados con tanruprubart (antes ANX005) para el tratamiento del Síndrome de Guillain-Barré (GBS). Las presentaciones, programadas del 17 al 20 de mayo de 2025 en Edimburgo, Reino Unido, mostrarán datos de efectividad comparativa y nuevos análisis de ensayos de Fase 3.
El GBS es una enfermedad autoinmune rara que causa debilidad rápida y posible parálisis, sin tratamientos aprobados por la FDA actualmente disponibles. Tanruprubart, un anticuerpo monoclonal innovador, se dirige a C1q para bloquear la activación de la cascada del complemento clásico. El medicamento busca detener la neuroinflamación y el daño nervioso durante la fase aguda del GBS con una única infusión.
Las presentaciones incluirán evidencia del mundo real que compara tanruprubart con tratamientos estándar, datos que vinculan la inhibición temprana del complemento con resultados a largo plazo, mejoras en la calidad de vida y eficacia en un amplio espectro de pacientes.
Annexon (NASDAQ: ANNX)은 2025년 말초신경학회 연례회의에서 길랭-바레 증후군(GBS) 치료를 위한 tanruprubart(이전 명칭 ANX005)의 개선된 결과를 발표할 예정입니다. 이 발표는 2025년 5월 17일부터 20일까지 영국 에든버러에서 열리며, 3상 임상시험의 비교 효과 데이터와 새로운 분석을 선보일 예정입니다.
GBS는 빠른 근력 저하와 마비를 초래하는 희귀 자가면역질환으로, 현재 FDA 승인 치료제가 없습니다. Tanruprubart는 최초의 단클론항체로 C1q를 표적으로 하여 고전적 보체 연쇄 반응의 시작을 차단합니다. 이 약물은 급성 GBS 단계에서 단회 주입으로 신경염증과 신경 손상을 차단하는 것을 목표로 합니다.
발표 내용에는 tanruprubart와 표준 치료법을 비교한 실제 증거, 조기 보체 억제가 장기 결과에 미치는 영향, 삶의 질 개선, 다양한 환자군에서의 효능 등이 포함될 것입니다.
Annexon (NASDAQ : ANNX) a annoncé des présentations à venir lors de la réunion annuelle 2025 de la Peripheral Nerve Society, mettant en lumière les résultats améliorés avec tanruprubart (anciennement ANX005) pour le traitement du syndrome de Guillain-Barré (SGB). Les présentations, prévues du 17 au 20 mai 2025 à Édimbourg, Royaume-Uni, présenteront des données d'efficacité comparative et de nouvelles analyses issues des essais de phase 3.
Le SGB est une maladie auto-immune rare provoquant une faiblesse rapide et une paralysie potentielle, sans traitements approuvés par la FDA à ce jour. Tanruprubart, un anticorps monoclonal innovant, cible C1q pour bloquer l'initiation de la cascade du complément classique. Ce médicament vise à stopper la neuroinflammation et les lésions nerveuses durant la phase aiguë du SGB par une seule perfusion.
Les présentations incluront des preuves du monde réel comparant tanruprubart aux traitements standards, des données reliant l'inhibition précoce du complément aux résultats à long terme, des améliorations de la qualité de vie et une efficacité sur un large spectre de patients.
Annexon (NASDAQ: ANNX) kündigte bevorstehende Präsentationen auf dem Jahreskongress der Peripheral Nerve Society 2025 an, bei denen verbesserte Ergebnisse mit tanruprubart (ehemals ANX005) zur Behandlung des Guillain-Barré-Syndroms (GBS) vorgestellt werden. Die Präsentationen, die vom 17. bis 20. Mai 2025 in Edinburgh, Großbritannien, stattfinden, zeigen vergleichende Wirksamkeitsdaten und neue Analysen aus Phase-3-Studien.
GBS ist eine seltene Autoimmunerkrankung, die rasche Schwäche und mögliche Lähmung verursacht, für die derzeit keine von der FDA zugelassenen Behandlungen existieren. Tanruprubart, ein neuartiger monoklonaler Antikörper, zielt auf C1q ab, um die Aktivierung der klassischen Komplementkaskade zu blockieren. Das Medikament soll durch eine Einmalinfusion die Neuroinflammation und Nervenschädigung während der akuten GBS-Phase stoppen.
Die Präsentationen umfassen Real-World-Daten, die tanruprubart mit Standardbehandlungen vergleichen, Daten, die einen Zusammenhang zwischen früher Komplementhemmung und langfristigen Ergebnissen zeigen, Verbesserungen der Lebensqualität sowie Wirksamkeit über ein breites Patientenspektrum.
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Insights
Annexon's tanruprubart shows promising Phase 3 results for GBS treatment, potentially becoming first targeted therapy for this serious neurological condition.
Annexon's presentations at the upcoming 2025 PNS Meeting highlight significant advancements for tanruprubart (formerly ANX005) in treating Guillain-Barré Syndrome (GBS). The data being presented seems particularly promising on multiple fronts. First, real-world evidence from the International GBS Outcomes Study shows that tanruprubart delivered improved outcomes compared to current standards of care (IVIg and plasma exchange) in matched patient populations - a crucial comparative effectiveness finding.
What makes this development clinically significant is that GBS is a neuromuscular emergency with no FDA-approved treatments. The disease progression can be devastating - rapidly advancing weakness that can lead to complete paralysis, often requiring mechanical ventilation. The current standards of care have limitations in efficacy and availability.
The mechanistic approach is notable - tanruprubart is a monoclonal antibody targeting C1q, the initiating molecule of the classical complement cascade. This represents a precise intervention at the source of neuroinflammation rather than the more generalized approach of current treatments. The single-infusion administration is also clinically advantageous compared to the multiple infusions required for IVIg or the complex procedure of plasma exchange.
The Phase 3 analyses indicate both early and durable treatment effects, suggesting tanruprubart may not only halt disease progression faster but maintain those benefits long-term. The improvements in quality of life measures further validate the clinical meaningfulness of these results. Additionally, the effective treatment across a "broad spectrum of patients" suggests versatility in treating various GBS presentations.
If approved, tanruprubart would represent a paradigm shift in GBS management - moving from non-specific immune modulation to targeted therapy addressing a specific pathological mechanism, potentially improving outcomes for this serious neurological emergency.
First Oral Presentation by the International Guillain-Barré Syndrome Outcomes Study (IGOS) of the Real-World Evidence (RWE) Results Showing Improved Outcomes with Tanruprubart (formerly ANX005) Compared to Current Standards of Care in Matched Patient Populations
New Analyses of Phase 3 Trial Highlight Tanruprubart’s Early and Durable Treatment Effect and Improvement in Quality of Life in Patients with GBS
BRISBANE, Calif., May 09, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced oral and poster presentations highlighting improved outcomes with tanruprubart (formerly ANX005) at the 2025 Peripheral Nerve Society (PNS) Annual Meeting at the Edinburgh International Conference Centre being held May 17-20, 2025 in Edinburgh, UK.
GBS is a neuromuscular emergency and rare autoimmune disease with no FDA-approved therapies that is characterized by rapidly progressing and severe weakness that can lead to complete paralysis, often requiring intensive care and mechanical ventilation. Tanruprubart is a first-in-kind monoclonal antibody designed to block C1q, the initiating molecule of the classical complement cascade, with a single infusion to halt ongoing neuroinflammation and nerve damage in the acute phase of GBS to improve and expedite overall recovery.
Oral Presentation
“Comparative Effectiveness in IGOS: ANX005 Versus Intravenous Immunoglobulin or Plasma Exchange for Guillain-Barré Syndrome”
- IGOS Presenter: Eveline Wiegers, M.D., Ph.D.
- Date/Time: Monday, May 19, from 3:55 pm to 4:10 pm British Summer Time (BST)
Poster Presentations
“Linking Early Complement Inhibition to Long-Term Outcomes in GBS: Objective Measures Support Tanruprubart (ANX005) Efficacy”
- Presenter: Glenn Morrison, Ph.D.
- Date/Time: Sunday May 18, from 2:30 pm to 3:20 pm BST
“Tanruprubart (ANX005) Improves Health-related Quality of Life in Patients with Guillain-Barré Syndrome Compared to Placebo”
- Presenter: Glenn Morrison, Ph.D.
- Date/Time: Monday, May 19, from 2:10 pm to 3:10 pm BST. Poster also selected as a flash oral presentation from 5:30 pm to 5:35 pm BST.
“Efficacy of Tanruprubart (ANX005) for Treatment of Guillain-Barré Syndrome in a Broad Spectrum of Patients”
- Presenter: Henk-André Kroon, M.D.
- Date/Time: Monday May 19, from 2:10 pm to 3:10 pm BST
About Tanruprubart (formerly ANX005)
Annexon’s lead investigational therapy, tanruprubart, is a first-of-its kind selective, targeted and rapid-acting agent designed to reduce inflammation and nerve damage by stopping C1q activity in the peripheral and central nervous systems. In GBS, tanruprubart is designed to seek out C1q and prevent its binding to targets on peripheral nerves. Tanruprubart is administered intravenously and has been observed to act almost immediately in blocking C1q function. The aim of an effective treatment in GBS is to rapidly stop the autoimmune damage on nerve cells, allowing patients to regain muscle strength sooner and to regain independence and return to pre-illness activities. Tanruprubart has received both Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration as well as orphan drug designation from the European Medicines Agency for the treatment of GBS.
About Guillain-Barré Syndrome (GBS)
GBS is a rare neuromuscular emergency resulting from an acute autoantibody and classical complement-mediated attack on peripheral nerves that generally occurs post-infection in otherwise healthy persons. It is an acute, rapidly progressive disease with a narrow timeframe for therapeutic intervention. GBS results in the hospitalization of more than 22,000 people annually in the U.S. and Europe. The peripheral nerve damage progresses rapidly, causing acute neuromuscular paralysis that can lead to significant morbidity, disability and mortality. Currently, there are no approved treatments for GBS in the U.S. The long-term disease burden associated with GBS has led to a multi-billion-dollar annual economic cost to the U.S. healthcare system alone. More information about the impact of GBS is available at MoveGBSForward.com.
About Annexon
Annexon Biosciences (Nasdaq: ANNX) is developing therapeutics that stop classical complement-driven neuroinflammation as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement’s potent inflammatory pathway that when misdirected can lead to tissue damage and loss. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade in disease before it starts. Our pipeline spans three diverse therapeutic areas – autoimmune, neurodegenerative and ophthalmic diseases – and includes targeted investigational drug candidates designed to address the unmet needs of over 8 million people worldwide. Annexon’s mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit annexonbio.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “suggest,” “target,” “on track,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, the ability of tanruprubart (formerly ANX005) to stop C1q activity in the peripheral and central nervous systems; the clinical and regulatory status of ANX005; and the potential therapeutic benefit of ANX005; the potential benefits from treatment with anti-C1q therapy; and continuing advancement of the company’s portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates; the effects of public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
Media Contact:
Sheryl Seapy
Real Chemistry
949-903-4750
sseapy@realchemistry.com
FAQ
What is tanruprubart and how does it treat Guillain-Barré Syndrome (GBS)?
What data will ANNX present at the 2025 PNS Meeting about tanruprubart?
Why is tanruprubart significant for GBS treatment?
When and where will Annexon present the tanruprubart data?
