BioArctic receives European substance patent for exidavnemab
Stockholm, April 22, 2025 - BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the European Patent Office, EPO, has issued a decision to grant European patent EP4172199B1 for exidavnemab, a drug candidate being developed as a treatment for synucleinopathies such as Parkinson's disease and Multiple System Atrophy (MSA). The patent enters into force on 14 May 2025 and expires in 2041, with the possibility of extension until 2046.
Exidavnemab is being developed as a novel disease-modifying treatment for synucleinopathies such as Parkinson's disease and MSA. Exidavnemab is a monoclonal antibody (mAb) that selectively targets alpha-synuclein aggregates, such as oligomers or protofibrils. Aggregated alpha-synuclein damages the nerve cells and as exidavnemab selectively binds and eliminates these aggregates, the neuronal function and survival may be preserved, and disease progression ultimately halted.
"Neurodegenerative diseases cause tremendous suffering worldwide, and we continue our work to develop treatments that delay or stop disease progression. The expanded patent protection for exidavnemab through a substance patent in the EU is further evidence of our innovation capacity and ability to identify completely new ways to tackle brain diseases," says Gunilla Osswald, CEO, BioArctic.
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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 April 23, 2025 at 13:00 CET.
For further information, please contact:
Charlotte af Klercker, Senior Director Sustainability and Communications
Phone: +46 73 515 09 70
E-mail: charlotte.afklercker@bioarctic.com
Anders Martin-Löf, CFO
Phone: +46 70 683 79 77
E-mail: anders.martin-lof@bioarctic.com
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 and Multiple System Atrophy (MSA). The goal is to develop a disease modifying treatment that stops or slow down the progression of alpha-synucleinopathies e.g. Parkinson's disease and MSA. BioArctic's phase 2a study EXIST with exidavnemab in Parkinson's disease is ongoing since 2024. EXIST is an important step towards a proof-of-concept study focusing on the efficacy of the drug candidate.
In March 2025, the US FDA Office of Orphan Products Development (OOPD) granted orphan drug designation (ODD) to exidavnemab for the treatment of MSA.
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 is the originator of 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 Eisai. BioArctic has a broad research portfolio within Alzheimer's disease, Parkinson's disease, ALS and enzyme deficiency diseases. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which improves the transport of drugs into the brain. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For more information, please visit www.bioarctic.com.