Study results from phase 1 studies with exidavnemab published in The Journal of Clinical Pharmacology
Rhea-AI Summary
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.
Positive
- 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
Negative
- 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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Study results from phase 1 studies with exidavnemab published in The Journal of Clinical Pharmacology |
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SOURCE BioArctic
FAQ
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