Salute e Benessere
BioArctic to initiate next cohorts in exidavnemab Phase 2a study after positive safety review
"Exidavnemab is BioArctic's second disease modifying treatment for severe brain diseases, building on a similar scientific approach as Leqembi®. Both originate from our antibody platform, selectively targeting aggregated, toxic misfolded proteins. I am pleased that the interim safety review of our phase 2a study EXIST of exidavnemab showed a good safety and tolerability profile as expected, supporting progression into higher doses in both Parkinson's disease and MSA," says Gunilla Osswald , CEO at BioArctic.
The Phase 2a study EXIST (EXIdavnemab Synucleinopathy Trial), is a randomized, double-blinded, placebo-controlled study to evaluate the safety and tolerability of exidavnemab and its pharmacokinetic profile. In addition, a broad range of biomarkers will be evaluated in plasma, cerebrospinal fluid (CSF), and using digital measurements.
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 pathological alpha-synuclein aggregates, while sparing the physiological forms. Aggregated alpha-synuclein damages nerve cells, and by selectively binding and removing these aggregates, exidavnemab is intended to preserve nerve cell function and slow the disease.
There is a large unmet medical need for slowing disease progression in diseases such as Parkinson's disease and MSA. Exidavnemab has recently been granted orphan drug designation (ODD) in the US and a positive opinion regarding orphan medicinal product designation (OD) in the EU for the treatment of MSA.
Oskar Bosson , VP Communications and Investor Relations
E-mail: mailto:oskar.bosson@bioarctic.com
Telephone: +46 70 410 71 80
Exidavnemab is a monoclonal antibody drug candidate that is designed to selectively target and eliminate pathological alpha-synuclein aggregates, while sparing the physiological forms. Aggregates of alpha-synuclein participate 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 is ongoing since 2024. EXIST is an important step towards a proof-of-concept study focusing on the efficacy of the drug candidate.
Exidavnemab has been granted orphan drug designation (ODD) in the US and a positive opinion regarding orphan medicinal product designation (OD) in the EU for the treatment of Multiple System Atrophy (MSA).
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.
This information was brought to you by Cision http://news.cision.com.
https://news.cision.com/bioarctic/r/bioarctic-to-initiate-next-cohorts-in-exidavnemab-phase-2a-study-after-positive-safety-review,c4163875
The following files are available for download:
View original content:https://www.prnewswire.co.uk/news-releases/bioarctic-to-initiate-next-cohorts-in-exidavnemab-phase-2a-study-after-positive-safety-review-302480954.html