Biogen ( BIIB Quick Quote BIIB - Free Report) announced that it is discontinuing one of the two studies on its and partner Denali Therapeutics’ ( DNLI Quick Quote DNLI - Free Report) small molecule LRRK2 inhibitor, BIIB122, for Parkinson’s disease.
Biogen’s clinical development program on BIIB122 initially comprised two late-stage studies. The first study was a phase IIb LUMA study in participants with early-stage Parkinson’s disease while the second study was a phase III LIGHTHOUSE study in patients with Parkinson’s disease associated with LRRK2 pathogenic mutations. LRRK2 mutations are one of the most common genetic drivers of Parkinson’s disease. While the LUMA study began in May 2022, the LIGHTHOUSE study commenced in September 2022.
Biogen has now decided to discontinue the LIGHTHOUSE study as it believes the study is complicated and will take several years to be completed. The LIGHTHOUSE study is expected to be completed in 2031, when the competitive landscape may also become intense. The protocol of the LUMA study will be amended to now include only some eligible patients with a LRRK2 genetic mutation in addition to continuing to enroll eligible patients with early-stage idiopathic Parkinson’s disease. Biogen will now focus on the LUMA study on BIIB122. Participants currently enrolled in the LIGHTHOUSE study can now join the LUMA study.
Biogen said these changes in BIIB122’s clinical program were not based on safety or efficacy data from any studies of the candidate.
Biogen’s stock has risen 9.1% this year so far against a decrease of 7.6% for the
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Biogen collaborated with Denali Therapeutics in August 2020 to co-develop and co-commercialize BIIB122 for Parkinson’s disease. In 2023, Biogen licensed Denali’s ATV-enabled anti-amyloid beta program.
Biogen decided to re-align its Parkinson’s disease program on BIIB122 as part of its ongoing R&D prioritization initiative. Biogen is focusing on R&D activities with the highest probability of success. It can accelerate, terminate, divest, or partner certain programs while continuing to evaluate new internal and external opportunities within its key therapeutic areas of focus and adjacencies, as part of the R&D initiative.
Zacks Rank & Stocks to Consider
Biogen currently has a Zacks Rank #3 (Hold).
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