BIIB094 / Ionis, Biogen - LARVOL DELTA

ION859, Which Targets LRRK2 RNA to Reduce CNS LRRK2 Protein Production, is Well-tolerated and Potently Reduces CSF LRRK2 Protein and pRAB10 Levels in Parkinson's Disease Patients (AAN 2025) - "Conclusions ION859 reduces total LRRK2 and the LRRK2 substrate pRab10 in CSF. The safety and pharmacodynamic profile support its advancement into later-stage development for patients with Parkinson's disease."

Clinical • Late-breaking abstract • CNS Disorders • Movement Disorders • Parkinson's Disease • CTSS • LRRK2 • RAB10

Trimmed pipeline (Firstwordpharma Press Release) - "Alongside its fourth-quarter results, Biogen said that as part of ongoing pipeline prioritisation efforts, it has discontinued development of: BIIB113 in early Alzheimer's disease; BIIB094 in early Parkinson's disease; BIIB101 in multiple system atrophy; and BIIB143 (cemdomespib) in diabetic peripheral neuropathic pain."

Discontinued • Alzheimer's Disease • Diabetic Neuropathy • Multiple System Atrophy • Parkinson's Disease • Peripheral Neuropathic Pain

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease (clinicaltrials.gov) - P1 | N=82 | Completed | Sponsor: Biogen | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Aug 2024 | Trial primary completion date: Dec 2024 ➔ Aug 2024

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease (clinicaltrials.gov) - P1 | N=81 | Active, not recruiting | Sponsor: Biogen | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease (clinicaltrials.gov) - P1 | N=82 | Recruiting | Sponsor: Biogen | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Recent advances in targeting leucine-rich repeat kinase 2 as a potential strategy for the treatment of Parkinson's disease. (PubMed, Bioorg Chem) - "Currently, five candidates, DNL201, DNL151, WXWH0226, NEU-723 and BIIB094, have advanced to clinical trials for PD treatment. In this review, we describe the structure, pathogenic mutations and the mechanism of LRRK2, and summarize the development of LRRK2 inhibitors in preclinical and clinical studies, trying to provide an insight into targeting LRRK2 for PD intervention in future."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease • LRRK2

DNL151, DNL201 and BIIB094: experimental agents for the treatment of Parkinson's disease. (PubMed, Expert Opin Investig Drugs) - "Approval of Leucine-rich repeat kinase 2 inhibitors in case of positive clinical study outcomes will introduce personalized medicine for beneficial modification of progression as the most unmet need for treatment of patients with Parkinson's disease. In addition to the currently, preponderantly performed clinical rating with established scales, further clinical trial endpoints, such as dosing of dopamine substitution, may be considered in study designs to demonstrate therapeutic effects on the progression of Parkinson's disease."

Journal • Review • CNS Disorders • Inflammation • Metabolic Disorders • Movement Disorders • Parkinson's Disease • LRRK2

Ionis reports first quarter financial results and recent business achievements (PRNewswire) - "Ionis Pharmaceuticals, Inc...today reported financial results for the first quarter of 2022 and recent business achievements....Biogen advanced the Phase 1/2 study of ION859 (BIIB094) targeting LRRK2 in patients with Parkinson's disease, resulting in a $10 million milestone payment from Biogen..."

Commercial • CNS Disorders • Parkinson's Disease

"$ions $biib has two phase 2 CNS drugs to treat Parkinsons: ION859 (LRRK2) and ION464 (SNCA)!" (@auditor112017)

P2 data • CNS Disorders • Movement Disorders • Parkinson's Disease

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease (clinicaltrials.gov) - P1; N=82; Recruiting; Sponsor: Biogen; Trial completion date: Dec 2022 ➔ Sep 2023; Trial primary completion date: Dec 2022 ➔ Sep 2023

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Ionis With Akcea: Still A Bargain (SeekingAlpha) - "BIIB094 (ION859) is partnered with Biogen for Parkinson's disease. Biogen has an option to acquire it from Ionis. It uses antisense RNA technology to reduce LRRK2 protein, which is associated with the disease. Phase 1 data is expected in 2022."

P1 data • CNS Disorders • Parkinson's Disease

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease (clinicaltrials.gov) - P1; N=82; Recruiting; Sponsor: Biogen; N=62 ➔ 82; Trial completion date: Jan 2022 ➔ Dec 2022; Trial primary completion date: Jan 2022 ➔ Dec 2022

Enrollment change • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease (clinicaltrials.gov) - P1; N=62; Recruiting; Sponsor: Biogen; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease (clinicaltrials.gov) - P1; N=62; Not yet recruiting; Sponsor: Biogen

Clinical • New P1 trial