Release Details

As part of its ongoing Research & Development (R&D) prioritization initiative and resource allocation, Biogen announced plans to revise the clinical development program for BIIB122, a small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2), which is being developed in collaboration with Denali Therapeutics Inc.

Prior to the planned revisions, the BIIB122 clinical development program encompassed two global late-stage clinical trials: the Phase 2b LUMA study in participants with early-stage Parkinson’s disease, which commenced in May 2022; and the Phase 3 LIGHTHOUSE study in participants with Parkinson’s disease related to LRRK2 mutations, which commenced in September 2022.

In consideration of the LIGHTHOUSE study’s complexity including the long timeline with anticipated study completion in 2031, Biogen and Denali have agreed that efforts will be refocused to enable a timely readout on efficacy in early-stage idiopathic Parkinson's disease while gaining further clinical data in Parkinson’s disease with and without a LRRK2 mutation.

The protocol for the LUMA study in patients with early-stage Parkinson’s disease will be amended to now include eligible patients with a LRRK2 genetic mutation in addition to continuing to enroll eligible patients with early-stage idiopathic Parkinson’s disease. The LIGHTHOUSE study of BIIB122 in patients with Parkinson’s disease associated with LRRK2 mutations will be discontinued. Patients currently enrolled and randomized in LIGHTHOUSE will be offered the opportunity to join the LUMA study.

These modifications are not based on any safety or efficacy data from studies of BIIB122. Denali and Biogen have a strategic collaboration to jointly develop and commercialize small molecule inhibitors of LRRK2 and remain committed to advancing the development of BIIB122.

Further information about LUMA (NCT05348785) can be accessed at clinicaltrials.gov. Participants currently enrolled and randomized in the LIGHTHOUSE study should speak to their physician regarding participation in LUMA or other treatment options.

Biogen Safe Harbor 
This press release contains forward-looking statements, relating to the potential benefits and results that may be achieved through Biogen’s collaboration with Denali; the potential benefits, safety and efficacy of BIIB122 (DNL151) and other LRRK2 inhibitor molecules; the clinical development program for BIIB122 (DNL151) and other LRRK2 inhibitor molecules; the potential benefits of Denali’s TV technology platform and TV programs including its ATV: anti-amyloid beta program; the treatment of Parkinson’s disease; the potential of Biogen’s commercial business and pipeline programs; Biogen’s strategy and plans; the potential treatment of neurological and neurodegenerative diseases; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

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