exidavnemab (BAN0805) / BioArctic - LARVOL DELTA

Exidavnemab phase 2a study expanded to include MSA patients (PRNewswire) - "BioArctic AB...announced today that regulatory authorities in Spain in Poland have approved the inclusion of Multiple System Atrophy (MSA) patients for treatment with the alpha-synuclein antibody exidavnemab in the ongoing EXIST Phase 2a study...The Phase 2a study EXIST (EXIdavnemab Synucleinopathy Trial), is a randomized, double-blinded, placebo-controlled study in Parkinson's disease patients to evaluate the safety and tolerability of exidavnemab, an alpha-synuclein antibody. The obtained regulatory approval of the substantial protocol modification enables inclusion of an additional cohort of Multiple System Atrophy (MSA) patients in the ongoing EXIST trial."

Trial status • Multiple System Atrophy

BioArctic receives European substance patent for exidavnemab (Cision) - "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."

Patent • Multiple System Atrophy • Parkinson's Disease

EXIDAVNEMAB (BAN0805) OFFERS OPPORTUNITIES AS A POTENTIAL DISEASE MODIFYING THERAPY IN SEVERAL SYNUCLEINOPATHIES (ADPD 2025) - "Moreover, exidavnemab almost completely depleted aggregated α-synuclein from brain extracts from patients with these pathologies. Conclusions These ex vivo studies using human brain tissue across four clinically defined states of synucleinopathy provide further support for the therapeutic rationale of exidavnemab to address the need for treatments that demonstrate slowing of disease progression."

IO biomarker • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Developmental Disorders • Lewy Body Disease • Movement Disorders • Multiple System Atrophy • Parkinson's Disease

BioArctic receives Orphan Drug Designation for exidavnemab the US (PRNewswire) - "BioArctic AB...announced today that the US FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation (ODD) to exidavnemab for the treatment of Multiple System Atrophy (MSA), providing incentives for the development of treatments for rare diseases with a high medical need."

Orphan drug • Multiple System Atrophy

First patient dosed in EXIST Phase 2a study in Parkinson's disease (PRNewswire) - "BioArctic AB...announced today that the first patient has been dosed with exidavnemab in the EXIST Phase 2a study, in Parkinson's disease patients. Exidavnemab is a monoclonal antibody designed to target aggregated forms of the protein α-synuclein, believed to play a role in the disease progression in different neurological disorders including Parkinson's disease."

Trial status • CNS Disorders • Parkinson's Disease

EXIST: Safety, Tolerability, and Pharmacokinetics of Exidavnemab in Patients with Parkinson's Disease (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: BioArctic AB

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Exidavnemab offers opportunities as a potential disease modifying therapy in several synucleinopathies (MDS Congress 2024) - "Taken together, the results from the ex vivo target engagement studies with human tissue and two clinical studies performed support the continued clinical development of exidavnemab in several synucleinopathies."

IO biomarker • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Lewy Body Disease • Multiple System Atrophy • Parkinson's Disease

Study results from phase 1 studies with exidavnemab published in The Journal of Clinical Pharmacology (PRNewswire) - P1 | N=98 | "BioArctic AB...announced today that the results from two phase-1 studies with exidavnemab have been published in The Journal of Clinical Pharmacology. Exidavnemab is a drug candidate under development aimed at treating diseases such as Parkinson's disease....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."

P1 data • CNS Disorders • Parkinson's Disease

Safety, Tolerability, and Pharmacokinetics of Single Doses of Exidavnemab (BAN0805), an Anti-α-Synuclein Antibody, in Healthy Western, Caucasian, Japanese, and Han Chinese Adults. (PubMed, J Clin Pharmacol) - "Dose-dependent reduction of free α-synuclein in plasma was observed. In summary, exidavnemab was found to have an excellent pharmacokinetic profile and was well tolerated in HVs, supporting the continued clinical development."

Journal • PK/PD data • Back Pain • CNS Disorders • Developmental Disorders • Infectious Disease • Movement Disorders • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Parkinson's Disease

The Construction and Validation of a Novel Ferroptosis-Related Gene Signature in Parkinson's Disease. (PubMed, Int J Mol Sci) - "Therapeutic drugs that target SNCA include ABBV-0805, Prasinezumab, Cinpanemab, and Gardenin A. The results of this study suggest that cellular DEF-MDRGs might play an important role in PD. AR, ISCU, SNCA, and PDK4 have the potential to be specific biomarkers for the early diagnosis of PD."

Gene Signature • Journal • CNS Disorders • Metabolic Disorders • Movement Disorders • Parkinson's Disease • Solid Tumor • Targeted Protein Degradation • MIR128 • MIR199A • MIR199B • MIR203A • MIR204 • MIR214 • PDK4 • SNCA

BioArctic receives patent in Japan for new antibodies targeting Parkinson's disease (PRNewswire) - "BioArctic AB...announced today that the Japanese Patent Office (JPO) is granting a new drug substance patent for the antibody BAN0805, invented by BioArctic as a potential treatment of Parkinson's disease. The patent will expire in 2041, with the possibility of a patent term extension up until 2046. The granted substance patent (based on Japanese patent application no. 2021-570377) focuses on the monoclonal antibody BAN0805, which selectively binds to and eliminates pathological aggregated forms called oligomers and protofibrils while sparing the physiological monomer form of alpha-synuclein."

Patent • CNS Disorders • Parkinson's Disease

BioArctic receives new drug substance patent in the US for ABBV-0805 against Parkinson’s disease (PRNewswire) - "BioArctic AB...announced today that the US Patent and Trademark Office (USPTO) has granted a new drug substance patent for the antibody ABBV-0805, invented by BioArctic as a potential treatment of Parkinson's disease. The patent will take effect on May 24, 2022, and expire in 2041, with the possibility of a patent term extension up until 2046. The granted substance patent (US patent no. 11,339,212) focuses on the monoclonal antibody ABBV-0805, which selectively binds to and eliminates pathological aggregated forms called oligomers and protofibrils while sparing the physiological monomer form of alpha-synuclein. The aim is to develop a treatment that halts or slows the progression of Parkinson's disease."

Patent • CNS Disorders • Parkinson's Disease

AbbVie terminates collaboration with BioArctic on alpha-synuclein portfolio (PRNewswire) - "BioArctic AB...has announced that the company's partner AbbVie has decided to terminate its collaboration with BioArctic regarding the portfolio of alpha-synuclein antibodies, including ABBV-0805....All available data indicates that ABBV-0805 has uniquely high selectivity for the pathological forms of aggregated alpha-synuclein, as well as Phase 1 data supporting progression to Phase 2."

Licensing / partnership • CNS Disorders • Parkinson's Disease

Interim Report for the period October - December 2021 (Market Screener) - "2022 will be the most exciting year in the company's history. It is the year we expect the results from the Phase 3 study of lecanemab in patients with early Alzheimer's disease, the completion of the rolling submission under the accelerated approval pathway in the US and AbbVie's commencement of the Phase 2 program with drug candidate ABBV-0805 against Parkinson's disease."

BLA • New P2 trial • P3 data • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

ABBV-0805, a novel antibody selective for soluble aggregated α-synuclein, prolongs lifespan and prevents buildup of α-synuclein pathology in mouse models of Parkinson's disease. (PubMed, Neurobiol Dis) - "ABBV-0805 selectively targets soluble toxic α-synuclein aggregates with a picomolar affinity and demonstrates excellent in vivo efficacy. Based on the strong preclinical findings described herein, ABBV-0805 has been progressed into clinical development as a potential disease-modifying treatment for Parkinson's disease."

Journal • Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease

New data published on ABBV-0805 in Neurobiology of Disease (PRNewswire) - "BioArctic AB...has published an article in Neurobiology of Disease describing new preclinical data for the investigational anti-α-synuclein antibody ABBV-0805....The data shows that ABBV-0805 selectively targets soluble toxic α-synuclein aggregates such as oligomers and protofibrils. In addition, ABBV-0805 displays a dose-dependent reduction of both soluble and insoluble α-synuclein aggregates in mice brains, preventing α-synuclein to spread, delaying motor-symptoms and prolonging the lifespan. Furthermore, binding of ABBV-0805 to pathological α-synuclein in postmortem brains of Parkinson's disease patients has also been observed."

Preclinical • CNS Disorders • Parkinson's Disease

"Nya data publicerade för ABBV-0805 i Neurobiology of Disease https://t.co/mWQv8gRvX9" (@CisionNews)

[VIRTUAL] ABBV-0805, a novel α-synuclein oligomer selective antibody, prolonged lifespan and prevented accumulation of α-synuclein pathology in mouse models of Parkinson's disease (MDS Congress 2021) - "ABBV-0805 selectively targets soluble toxic α-synuclein oligomers with a high affinity and demonstrates excellent in vivo efficacy. Based on the strong preclinical findings, ABBV-0805 has been progressed into clinical development as a potential disease-modifying treatment for Parkinson's disease."

Preclinical • CNS Disorders • Parkinson's Disease

[VIRTUAL] Evaluating Engagement of ABBV-0805, an Anti-Alpha-Synuclein Monoclonal Antibody to Physiological and Pathological Forms of Alpha-Synuclein for Phase 2 Dose Selection: A PBPK Modeling and Simulation Approach (MDS Congress 2021) - "This PBPK/PD modeling approach was used to identify monthly intravenous Phase 2 doses of ABBV-0805 to maintain ≥ 95% oligomeric α-synuclein binding in CSF at steady state in PD patients."

P2 data • CNS Disorders • Parkinson's Disease

[VIRTUAL] Randomized, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-0805, an Anti-Alpha-Synuclein Monoclonal Antibody in Healthy Subjects (MDS Congress 2021) - "Preliminary human exposure, biomarker and safety data being gathered in an ongoing Phase 1 FIH study supports Phase 2 development of ABBV-0805."

Clinical • PK/PD data • CNS Disorders • Parkinson's Disease

New data presented at MDS Congress of ABBV-0805 in Parkinson's disease (PRNewswire) - "BioArctic AB...will present new preclinical data for...ABBV-0805 at the International Congress of Parkinson's disease and movement disorders® (MDS), held virtually September 17 to 22, 2021. The presentation...includes data showing ABBV-0805's ability to selectively target soluble toxic α-synuclein aggregates. BioArctic will present one abstract at the congress, focusing on the preclinical findings...support ABBV-0805 for development in Parkinson's disease....The data to be presented shows that ABBV-0805 selectively targets soluble toxic α-synuclein aggregates such as oligomers and protofibrils. In addition, ABBV-0805 displays a dose-dependent reduction of both soluble and insoluble α-synuclein aggregates in mice brains, preventing α-synuclein to spread, delaying motor-symptoms and prolonging the lifespan. Furthermore, binding of ABBV-0805 to pathological α-synuclein in postmortem brains of Parkinson's disease patients has also been observed."

Preclinical • CNS Disorders • Parkinson's Disease

Edited Transcript of BIOAb.ST earnings conference call or presentation 10-Jul-20 7:30am GMT (Yahoo Finance) - "...AbbVie, has decided to stop recruitment for the Phase I multiple ascending dose study of ABBV-0805 in Parkinson's disease patients. Phase I is continuing with a single ascending dose study. A detailed plan to accelerate the project into Phase II in Parkinson's disease patients is currently being prepared by AbbVie....Our Parkinson's early program, together with AbbVie, is also progressing well....And in Parkinson's disease, we look forward to the continued Phase I study being completed and AbbVie's preparation for the Phase II program."

Enrollment status • Trial status • CNS Disorders • Parkinson's Disease

A Study to Evaluate the Safety and Tolerability of ABBV-0805 in Patients With Parkinson's Disease (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: AbbVie; N=32 ➔ 0; Trial completion date: Jul 2021 ➔ Jun 2020; Recruiting ➔ Withdrawn; Trial primary completion date: Jul 2021 ➔ Jun 2020

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • CNS Disorders • Gene Therapies • Movement Disorders • Parkinson's Disease

BAN0805: IND submission in US for Parkinson's disease in H1 2019 (BioArctic Neuroscience) - Annual General Meeting

IND • Parkinson's Disease

BioArctic's Patent for its product candidate antibody BAN0805, for Parkinson's disease, is now granted in Europe (PRNewswire) - "BioArctic AB...today announced that the European Patent Office (EPO) has decided to grant a European patent (EP2539366) to BioArctic AB and the patent will be published on November 08, 2017. The European patent EP2539366 covers the monoclonal antibody candidate BAN0805 per se, intended for treatment of neurodegenerative disorders, including Parkinson's disease. Validated national patents will expire on February 25, 2031..."

Patent • Parkinson's Disease