BioArctic Ingeniously Advances Parkinson's Treatment with first Patient Dosed in EXIST Phase 2a Study
In a groundbreaking development for Parkinson's disease treatment, BioArctic AB has officially dosed the very first patient in its EXIST Phase 2a clinical study. This important milestone was announced on December 5, 2024, showcasing the company's dedication to combatting neurodegenerative disorders that impact countless lives.
The drug in focus, exidavnemab, is a monoclonal antibody explicitly designed to target aggregated forms of the α-synuclein protein. This protein is believed to significantly contribute to the progression of Parkinson’s disease and several other neurodegenerative disorders. The EXIST (EXIdavnemab Synucleinopathy Trial) study will assess the safety and tolerability of exidavnemab through a randomized, double-blind, placebo-controlled format, involving at least 24 Parkinson’s disease patients.
Participants of the study are divided into two groups: the first group will receive a lower dose of exidavnemab or a placebo, while the second group will be administered a higher dose of the drug or a placebo. This design allows for meticulous analysis of the drug's effects on both cohorts, thereby establishing a comprehensive safety profile.
Gunilla Osswald, CEO of BioArctic, expressed excitement about this crucial step, stating, "We are very excited that the first patient with Parkinson's disease has now been dosed in the EXIST Phase 2a study with exidavnemab. 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." This enthusiasm reflects the company’s commitment to advancing research and developing effective treatments.
Moreover, the existing studies from Phase 1 of exidavnemab, conducted in collaboration with AbbVie, published in The Journal of Clinical Pharmacology, revealed promising results. These studies confirmed that exidavnemab is generally well-tolerated by patients and highlighted its remarkable half-life of approximately 30 days. Such data fortify the decision to move into this Phase 2a study, as they ensure that the drug maintains a high affinity and selectivity for targeting pathological aggregated forms of α-synuclein in the brain, which is critical for treating the disease effectively.
The primary endpoints of the EXIST study will include a thorough assessment of a wide range of biomarkers found in plasma and cerebrospinal fluid (CSF), as well as evaluations through digital measurements. The outcomes of this Phase 2a trial will be pivotal in determining the feasibility of exidavnemab as a potential therapeutic option for patients with Parkinson’s disease.
It is worth noting that this communication discusses investigational uses of a developing agent and is not a definitive indication of its efficacy or safety. There exists no assurance that the investigational agents involved in this study will successfully complete the clinical development process or receive approval from health authorities. Nonetheless, the initiation of the EXIST trial marks a significant advancement in the journey toward innovative treatments for Parkinson’s disease.
BioArctic AB remains at the forefront of research-based biopharma in Sweden, concentrating on inventive solutions that aim to slow or prevent the progression of neurodegenerative diseases. The company is known for its remarkable innovation, having previously developed Leqembi® (lecanemab), which is recognized as the world’s first drug to slow cognitive decline in early Alzheimer’s disease.
As BioArctic continues to make strides in the world of neuroscience, the impact of their ongoing research and development efforts may potentially transform the lives of patients struggling with neurological disorders, offering hope for a brighter future. For further details on BioArctic and their initiatives, visit bioarctic.com.
The drug in focus, exidavnemab, is a monoclonal antibody explicitly designed to target aggregated forms of the α-synuclein protein. This protein is believed to significantly contribute to the progression of Parkinson’s disease and several other neurodegenerative disorders. The EXIST (EXIdavnemab Synucleinopathy Trial) study will assess the safety and tolerability of exidavnemab through a randomized, double-blind, placebo-controlled format, involving at least 24 Parkinson’s disease patients.
Participants of the study are divided into two groups: the first group will receive a lower dose of exidavnemab or a placebo, while the second group will be administered a higher dose of the drug or a placebo. This design allows for meticulous analysis of the drug's effects on both cohorts, thereby establishing a comprehensive safety profile.
Gunilla Osswald, CEO of BioArctic, expressed excitement about this crucial step, stating, "We are very excited that the first patient with Parkinson's disease has now been dosed in the EXIST Phase 2a study with exidavnemab. 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." This enthusiasm reflects the company’s commitment to advancing research and developing effective treatments.
Moreover, the existing studies from Phase 1 of exidavnemab, conducted in collaboration with AbbVie, published in The Journal of Clinical Pharmacology, revealed promising results. These studies confirmed that exidavnemab is generally well-tolerated by patients and highlighted its remarkable half-life of approximately 30 days. Such data fortify the decision to move into this Phase 2a study, as they ensure that the drug maintains a high affinity and selectivity for targeting pathological aggregated forms of α-synuclein in the brain, which is critical for treating the disease effectively.
The primary endpoints of the EXIST study will include a thorough assessment of a wide range of biomarkers found in plasma and cerebrospinal fluid (CSF), as well as evaluations through digital measurements. The outcomes of this Phase 2a trial will be pivotal in determining the feasibility of exidavnemab as a potential therapeutic option for patients with Parkinson’s disease.
It is worth noting that this communication discusses investigational uses of a developing agent and is not a definitive indication of its efficacy or safety. There exists no assurance that the investigational agents involved in this study will successfully complete the clinical development process or receive approval from health authorities. Nonetheless, the initiation of the EXIST trial marks a significant advancement in the journey toward innovative treatments for Parkinson’s disease.
BioArctic AB remains at the forefront of research-based biopharma in Sweden, concentrating on inventive solutions that aim to slow or prevent the progression of neurodegenerative diseases. The company is known for its remarkable innovation, having previously developed Leqembi® (lecanemab), which is recognized as the world’s first drug to slow cognitive decline in early Alzheimer’s disease.
As BioArctic continues to make strides in the world of neuroscience, the impact of their ongoing research and development efforts may potentially transform the lives of patients struggling with neurological disorders, offering hope for a brighter future. For further details on BioArctic and their initiatives, visit bioarctic.com.
Topics Health）
【About Using Articles】
You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.
【About Links】
Links are free to use.