BioArctic to initiate next cohorts in exidavnemab Phase 2a study after positive safety review

BioArctic to initiate next cohorts in exidavnemab Phase 2a study after positive safety review

By, Admin 13 June 2025

Overview

BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) announced today that the interim safety review of the clinical Phase 2a study EXIST showed exidavnemab to be safe and well-tolerated, whereby the second dose cohorts will now be initiated. The EXIST study evaluates exidavnemab, a drug candidate being developed as a treatment for Parkinson's disease and Multiple System Atrophy (MSA).

Evaluation of exidavnemab

  • The first cohort in the ongoing clinical Phase 2a study EXIST evaluated a lower dose of exidavnemab compared to placebo in patients with Parkinson's disease. 
  • An interim safety review showed that exidavnemab was safe and well tolerated. 
  • The positive outcome will result in the initiation of two further cohorts, to evaluate a higher dose of exidavnemab in comparison with placebo in patients with Parkinson's disease as well as MSA.

Statement from the CEO: BioArctic

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.

Phase 2a study EXIST trial

  • 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.

Development of Exidavnemab

  • 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.

Exidavnemab Gains Orphan Drug Designation for MSA Treatment

  • Parkinson’s disease & MSA face significant unmet medical needs in disease progression.
  • Exidavnemab has received Orphan Drug Designation (ODD) in the U.S. and positive opinion for OD in the EU for treating Multiple System Atrophy (MSA).
  • The release discusses investigational use, with no guarantee of approval or clinical success.
  • Disclosed by BioArctic AB (publ) under the EU Market Abuse Regulation on June 13, 2025, at 08:00 CET.

For further information, please contact:
Oskar Bosson, VP Communications and Investor Relations
E-mail: mailto: oskar.bosson@bioarctic.com
Telephone: +46 70 410 71 80

About Exidavnemab

  • 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).

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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!