First patient dosed in EXIST Phase 2a study in Parkinson's disease
Rhea-AI Summary
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.
Positive
- 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
Negative
- 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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First patient dosed in EXIST Phase 2a study in Parkinson’s disease |
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SOURCE BioArctic
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