First patient dosed in EXIST Phase 2a study in Parkinson's disease
BioArctic AB has initiated dosing in the EXIST Phase 2a study of exidavnemab for Parkinson's disease patients. The study is a randomized, double-blind, placebo-controlled trial evaluating safety and tolerability of the monoclonal antibody targeting aggregated α-synuclein. At least 24 patients will be recruited in Europe, divided into two cohorts receiving different doses.
The trial follows successful Phase 1 studies showing exidavnemab is well-tolerated with a 30-day half-life. The drug demonstrates high affinity and selectivity toward pathological aggregated forms of α-synuclein, which is believed to play a role in disease progression. The study will evaluate various biomarkers in plasma, cerebrospinal fluid, and through digital measurements.
BioArctic AB ha avviato la somministrazione nel studio di fase 2a EXIST con exidavnemab per pazienti affetti da malattia di Parkinson. Lo studio è un trial randomizzato, in doppio cieco e controllato con placebo che valuta la sicurezza e la tollerabilità dell'anticorpo monoclonale mirato alle forme aggregate di α-sinucleina. Almeno 24 pazienti saranno reclutati in Europa, suddivisi in due gruppi che riceveranno dosi differenti.
Il trial segue studi di fase 1 di successo che dimostrano che exidavnemab è ben tollerato con una emivita di 30 giorni. Il farmaco mostra alta affinità e selettività verso le forme aggregate patologiche di α-sinucleina, che si ritiene svolgano un ruolo nella progressione della malattia. Lo studio valuterà vari biomarcatori nel plasma, nel liquido cerebrospinale e attraverso misurazioni digitali.
BioArctic AB ha iniciado la dosificación en el estudio de fase 2a EXIST con exidavnemab para pacientes con enfermedad de Parkinson. El estudio es un ensayo aleatorizado, doble ciego y controlado con placebo que evalúa la seguridad y tolerabilidad del anticuerpo monoclonal dirigido a las formas agregadas de α-sinucleína. Se reclutarán al menos 24 pacientes en Europa, divididos en dos cohortes que recibirán diferentes dosis.
El ensayo sigue a estudios de fase 1 exitosos que demuestran que exidavnemab es bien tolerado con una vida media de 30 días. El fármaco muestra alta afinidad y selectividad hacia las formas agregadas patológicas de α-sinucleína, que se cree que juega un papel en la progresión de la enfermedad. El estudio evaluará varios biomarcadores en plasma, líquido cefalorraquídeo y mediante mediciones digitales.
BioArctic AB는 파킨슨병 환자를 위한 exidavnemab의 EXIST 2a 단계 연구에서 투여를 시작했습니다. 이 연구는 응집된 α-시누클레인을 표적으로 하는 단클론 항체의 안전성과 내약성을 평가하는 무작위 이중 맹검 위약 대조 시험입니다. 유럽에서 최소 24명의 환자가 모집되며, 서로 다른 용량을 받는 두 개의 집단으로 나누어질 것입니다.
이 시험은 30일의 반감기를 가지고 잘 견디는 exidavnemab를 보여주는 성공적인 1상 연구에 이어 진행됩니다. 이 약물은 질병 진행과 관련이 있다고 여겨지는 병리학적으로 응집된 α-시누클레인의 형태에 대해 높은 친화도와 선택성을 나타냅니다. 연구는 혈장, 뇌척수액에서 다양한 바이오마커를 평가하고 디지털 측정을 통해 조사할 것입니다.
BioArctic AB a lancé l'administration dans l'étude de phase 2a EXIST avec exidavnemab pour des patients atteints de la maladie de Parkinson. L'étude est un essai randomisé, en double aveugle et contrôlé par placebo qui évalue la sécurité et la tolérabilité de l'anticorps monoclonal ciblant les agrégats d'α-synucléine. Au moins 24 patients seront recrutés en Europe, répartis en deux cohortes recevant différentes doses.
L'essai fait suite à des études de phase 1 réussies montrant qu'exidavnemab est bien toléré avec une demi-vie de 30 jours. Le médicament démontre une forte affinité et sélectivité envers les formes agrégées pathologiques d'α-synucléine, qui serait impliquée dans la progression de la maladie. L'étude évaluera divers biomarqueurs dans le plasma, le liquide céphalorachidien et par le biais de mesures numériques.
BioArctic AB hat die Dosisverabreichung in der EXIST Phase 2a Studie mit exidavnemab für Parkinson-Patienten eingeleitet. Die Studie ist eine randomisierte, doppelblinde, placebokontrollierte Studie zur Bewertung der Sicherheit und Verträglichkeit des monoklonalen Antikörpers, der auf aggregierte α-Synuklein abzielt. Mindestens 24 Patienten werden in Europa rekrutiert, aufgeteilt in zwei Kohorten, die unterschiedliche Dosen erhalten.
Die Studie folgt erfolgreichen Phase 1 Studien, die zeigen, dass exidavnemab gut vertragen wird und eine Halbwertszeit von 30 Tagen hat. Das Medikament zeigt eine hohe Affinität und Selektivität gegenüber pathologisch aggregierten Formen von α-Synuklein, von denen angenommen wird, dass sie eine Rolle beim Fortschreiten der Krankheit spielen. Die Studie wird verschiedene Biomarker im Plasma, Liquor cerebrospinalis und durch digitale Messungen bewerten.
- Successful completion of Phase 1 studies showing good tolerability
- Drug demonstrates 30-day half-life, indicating favorable dosing potential
- Advancement to Phase 2a clinical trials indicates development progress
- None.
Insights
The initiation of the EXIST Phase 2a study for exidavnemab represents a significant milestone in BioArctic's development pipeline. The study's design as a randomized, double-blind, placebo-controlled trial with 24 patients across two dose cohorts provides a solid foundation for evaluating safety and tolerability in Parkinson's disease patients.
Previously published Phase 1 data showing a favorable 30-day half-life and good tolerability profile strengthens the potential of this α-synuclein targeting antibody. The inclusion of multiple biomarker measurements (plasma, CSF and digital) will provide comprehensive data on the drug's biological effects.
While this is an early-stage trial focusing primarily on safety, the strategic expansion into Parkinson's disease could significantly expand BioArctic's market opportunity beyond their existing neurodegenerative disease programs. However, investors should note that Phase 2a results will be important in determining the program's future potential.
This development holds strategic importance for BioArctic, with a current market cap of
The trial's initiation triggers potential milestone payments and positions BioArctic to potentially capture value in the growing neurodegenerative disease market. However, investors should consider that Phase 2a studies typically take 12-18 months to complete and success is not guaranteed. The company's financial runway and partnership strategy will be important factors to monitor during this development phase.
The Phase 2a study EXIST (EXIdavnemab Synucleinopathy Trial), is a randomized, double-blind, placebo-controlled study in Parkinson's disease patients to evaluate the safety and tolerability of exidavnemab. The study is conducted in
"We are very excited that the first patient with Parkinson's disease has now been dosed in the EXIST Phase 2a study with exidavnemab," said Gunilla Osswald, CEO at BioArctic. "It marks an important next step on BioArctic's pioneering journey to broaden our research portfolio and help more patients and families with different neurological disorders to a better life."
Recently, the results of two separate Phase 1 studies of exidavnemab, conducted in collaboration with AbbVie, were published in The Journal of Clinical Pharmacology. The results showed that exidavnemab is generally well-tolerated, with an excellent half-life of approximately 30 days. These data together with the high affinity and selectivity toward the pathological aggregated forms of α-synuclein, key to maintaining a high target binding in the brain, laid the foundation for the Phase 2a study.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.
The information was released for public disclosure, through the agency of the contact person below, on December 5, 2024, at 08:00 a.m. CET.
For further information, please contact:
Oskar Bosson, Vice President Communications and Investor Relations
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80
About Exidavnemab
Exidavnemab is a monoclonal antibody drug candidate that is designed to selectively bind and eliminate pathological aggregated forms of alpha-synuclein such as oligomers and protofibrils as well as fibrillar forms, all of which are believed to play a role in neurodegenerative disorders including Parkinson's disease. The goal is to develop a disease modifying treatment that stops or slows down the progression of Parkinson's disease or other synucleinopathies.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.
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SOURCE BioArctic
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