Study results from phase 1 studies with exidavnemab published in The Journal of Clinical Pharmacology
BioArctic AB (Nasdaq Stockholm: BIOA B) has announced the publication of results from two phase 1 studies of exidavnemab in The Journal of Clinical Pharmacology. Exidavnemab is a monoclonal antibody targeting aggregated forms of α-synuclein, aimed at treating diseases like Parkinson's disease. The studies, conducted with AbbVie, involved 98 healthy volunteers, with 85 receiving exidavnemab. Results showed that exidavnemab was generally well-tolerated with an excellent half-life of approximately 30 days. The drug's high affinity and selectivity toward pathological α-synuclein aggregates are key for maintaining high target binding in the brain. CEO Gunilla Osswald expressed anticipation for starting the phase 2a study later this year.
BioArctic AB (Nasdaq Stockholm: BIOA B) ha annunciato la pubblicazione dei risultati di due studi di fase 1 su exidavnemab nel The Journal of Clinical Pharmacology. Exidavnemab è un anticorpo monoclonale che mira alle forme aggregate dell'α-sinucleina, indirizzato al trattamento di malattie come il morbo di Parkinson. Gli studi, condotti con AbbVie, hanno coinvolto 98 volontari sani, di cui 85 hanno ricevuto exidavnemab. I risultati hanno mostrato che exidavnemab era generalmente ben tollerato con un'ottima emivita di circa 30 giorni. L'alta affinità e selettività del farmaco verso gli aggregati patologici dell'α-sinucleina sono cruciali per mantenere un elevato legame con il bersaglio nel cervello. L'Amministratore Delegato Gunilla Osswald ha espresso entusiasmo per l'inizio del studio di fase 2a più tardi quest'anno.
BioArctic AB (Nasdaq Estocolmo: BIOA B) ha anunciado la publicación de los resultados de dos estudios de fase 1 de exidavnemab en The Journal of Clinical Pharmacology. Exidavnemab es un anticuerpo monoclonal que se dirige a las formas agregadas de α-sinucleína, con el objetivo de tratar enfermedades como el morbo de Parkinson. Los estudios, realizados con AbbVie, involucraron a 98 voluntarios sanos, de los cuales 85 recibieron exidavnemab. Los resultados mostraron que exidavnemab fue generalmente bien tolerado con una vida media excelente de aproximadamente 30 días. La alta afinidad y selectividad del fármaco hacia los agregados patológicos de α-sinucleína son clave para mantener un alto nivel de unión al objetivo en el cerebro. La CEO Gunilla Osswald expresó anticipación por el inicio del estudio de fase 2a más adelante este año.
BioArctic AB (나스닥 스톡홀름: BIOA B)는 exidavnemab에 대한 두 개의 1상 연구 결과를 The Journal of Clinical Pharmacology에 발표했다고 밝혔다. Exidavnemab는 α-시뉴클레인의 집합체 형태를 표적으로 하는 단일클론 항체로, 파킨슨병과 같은 질병 치료를 목표로 한다. AbbVie와 함께 수행된 이 연구는 98명의 건강한 자원자를 대상으로 하였으며, 이 중 85명이 exidavnemab를 투여받았다. 결과는 exidavnemab가 전반적으로 잘 견딜 수 있었다고 보여주었으며 약 30일의 우수한 반감기를 기록했다. 이 약물의 병리학적 α-시뉴클레인 집합체에 대한 높은 친화도와 선택성은 뇌에서 높은 표적 결합을 유지하는 데 핵심적이다. CEO Gunilla Osswald는 올해 말에 2a상 연구를 시작하기를 기대하고 있다고 전했다.
BioArctic AB (Nasdaq Stockholm: BIOA B) a annoncé la publication des résultats de deux études de phase 1 concernant exidavnemab dans The Journal of Clinical Pharmacology. Exidavnemab est un anticorps monoclonal ciblant les formes agrégées de l'α-synucléine, visant à traiter des maladies telles que la maladie de Parkinson. Les études, menées avec AbbVie, ont impliqué 98 volontaires en bonne santé, dont 85 ont reçu exidavnemab. Les résultats ont montré qu'exidavnemab était généralement bien toléré avec une demi-vie excellente d'environ 30 jours. La haute affinité et sélectivité du médicament pour les agrégats pathologiques d'α-synucléine sont essentielles pour maintenir une forte liaison avec la cible dans le cerveau. La PDG Gunilla Osswald a exprimé son anticipation de commencer l'étude de phase 2a plus tard cette année.
BioArctic AB (Nasdaq Stockholm: BIOA B) hat die Veröffentlichung der Ergebnisse von zwei Phase-1-Studien zu exidavnemab im The Journal of Clinical Pharmacology angekündigt. Exidavnemab ist ein monoklonaler Antikörper, der auf die aggregierten Formen von α-Synuclein abzielt, um Krankheiten wie Morbus Parkinson zu behandeln. Die Studien, die in Zusammenarbeit mit AbbVie durchgeführt wurden, umfassten 98 gesunde Probanden, von denen 85 exidavnemab erhielten. Die Ergebnisse zeigten, dass exidavnemab im Allgemeinen gut vertragen wurde und eine Halbwertszeit von etwa 30 Tagen aufwies. Die hohe Affinität und Selektivität des Medikaments gegenüber pathologischen α-Synuclein-Aggregaten sind entscheidend für die Aufrechterhaltung einer hohen Zielbindung im Gehirn. CEO Gunilla Osswald äußerte die Erwartung, später in diesem Jahr mit der Phase-2a-Studie zu beginnen.
- Exidavnemab showed general good tolerability in phase 1 studies
- Drug candidate demonstrated an excellent half-life of approximately 30 days
- High affinity and selectivity toward pathological α-synuclein aggregates observed
- Phase 2a study planned to start later this year
- None.
Insights
The phase 1 study results for exidavnemab are promising for BioArctic's Parkinson's disease treatment pipeline. Key findings include:
- Generally well-tolerated across a wide dose range (100-6000 mg IV, 300 mg SC)
- Excellent half-life of ~30 days, suggesting potential for less frequent dosing
- High affinity and selectivity for pathological α-synuclein aggregates
These characteristics are important for maintaining effective brain target engagement. The planned phase 2a study will be critical to assess efficacy and further safety in Parkinson's patients. While promising, it's important to note that many candidates fail in later-stage trials, so cautious optimism is warranted.
The pharmacokinetic profile of exidavnemab is impressive. A 30-day half-life is exceptional for a monoclonal antibody, potentially allowing for monthly or even less frequent dosing. This could significantly improve patient compliance and quality of life compared to more frequently administered treatments.
The selectivity for aggregated α-synuclein while sparing the physiological form is crucial, as it may reduce off-target effects. However, the true test will be in later-phase trials, where we'll see if this selectivity translates to a meaningful clinical benefit without unexpected side effects from long-term α-synuclein modulation.
In two separate phase 1 clinical studies conducted in collaboration with AbbVie, exidavnemab was tested on healthy volunteers to assess the safety, tolerability and pharmacokinetics of the candidate drug. The studies included 98 participants from different ethnic backgrounds, of which 85 received exidavnemab, either as an intravenous dose ranging from 100 to 6000 mg or a subcutaneous dose of 300 mg.
The results showed that exidavnemab was generally well-tolerated. with an excellent half-life of approximately 30 days. This together with the high affinity and selectivity toward the pathological aggregated forms of α-synuclein is key to maintain a high target binding in the brain.
"Data from these two studies support the continued clinical development of exidavnemab, and we are looking forward to starting the phase 2a study later this year," said Gunilla Osswald, CEO of BioArctic, in a comment.
The published article can be read in full here: https://accp1.onlinelibrary.wiley.com/doi/10.1002/jcph.6103
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 August 27, 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
Jiang Millington, Corporate Communication and Social Media Director
E-mail: jiang.millington@bioarctic.se
Phone: +46 79 33 99 166
About Exidavnemab
Exidavnemab is a monoclonal antibody drug candidate that is designed to selectively bind and eliminate aggregated forms of alpha-synuclein such as oligomers and protofibrils and fibrillar forms, which participates in neurodegenerative disorders including Parkinson's disease. The goal is to develop a disease modifying treatment that stops or slow down the progression of Parkinson's disease.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on disease-modifying treatments for neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and ALS. BioArctic focuses on innovative treatments in areas with high unmet medical needs. The company was founded in 2003 based on innovative research from Uppsala University,
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SOURCE BioArctic
FAQ
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