Denali Therapeutics Announces First Participant Dosed in Phase 2a Study of LRRK2 Inhibitor, BIIB122, in LRRK2-Associated Parkinson’s Disease

Denali Therapeutics announced the start of its global Phase 2a BEACON clinical trial for BIIB122 (DNL151), an investigational drug targeting Parkinson’s disease linked to mutations in the LRRK2 gene. The trial will assess the drug’s safety and biomarker effects in about 50 participants with genetically confirmed LRRK2-associated Parkinson’s disease (LRRK2-PD). The study includes a 12-week double-blind treatment phase followed by an open-label extension. BIIB122 is a brain-penetrant LRRK2 inhibitor designed to address lysosomal dysfunction, which is thought to contribute to Parkinson’s disease progression. The Phase 2a study is led by Denali under its Investigational New Drug application, with funding from a collaboration agreement. Additionally, the drug is being studied in the ongoing Phase 2b LUMA trial with Biogen, involving participants with early-stage Parkinson’s disease, including those without LRRK2 mutations. Denali’s Chief Medical Officer, Carole Ho, expressed enthusiasm about the potential of BIIB122, highlighting the importance of collaborating with the Parkinson’s community to explore its impact. Todd Sherer, Chief Mission Officer at The Michael J. Fox Foundation, noted the significance of LRRK2 as a target for advancing disease-modifying therapies. Mutations in the LRRK2 gene are a known genetic factor in Parkinson’s disease, accounting for up to 5% of familial cases and 2% of sporadic cases. BIIB122 is not yet approved, and its safety and efficacy are still under investigation.