Biogen, Denali begin late-stage testing of Parkinson’s drug

Biogen and Denali Therapeutics said Monday that a late-stage study evaluating their experimental drug for Parkinson’s disease has started to dose patients, marking the latest milestone in a research collaboration the companies inked two years ago.

The study aims to enroll about 400 participants who test positive for what research indicates is one of the most common genetic drivers of Parkinson’s: mutations in a gene called LRRK2. The drug Biogen and Denali are co-developing, now named BIIB122, is meant to stifle LRRK2, and is being tested against a placebo to see if it can significantly slow the worsening of symptoms in patients with early-stage Parkinson’s.

Biogen’s head of neurodegeneration development, Samantha Budd Haeberlein, said in a statement that the study, dubbed LIGHTHOUSE, is the largest ever focused on Parkinson’s patients whose disease is caused by LRKK2 mutations. Results from the trial are expected in early 2031, according to a federal clinical trials database. 

Biogen and Denali are also conducting a mid-stage trial of BIIB122 in Parkinson’s patients who don’t have these mutations. That trial is trying to enroll around 640 patients, and should produce results in 2025.

Denali, a biotechnology company based just outside of San Francisco, originally teamed up with Biogen in 2020. In exchange for a $560 million upfront payment and a $465 million equity investment in Denali, Biogen secured rights to co-develop and co-commercialize the biotech’s small molecule drugs designed to treat Parkinson’s by targeting LRRK2.

In addition to its initial payments, Biogen agreed to pay Denali up to about $1.1 billion if the LRRK2 program achieves certain development and commercial milestones. Terms of the deal hold that Biogen and Denali split global development costs 60-40, while potential profits and losses from commercialization in the U.S. would be shared equally.

Biogen has another Parkinson’s drug that targets LRRK2, through a partnership with Ionis Pharmaceuticals. Called BIIB094, the drug uses a gene-silencing technology developed by Ionis. Its safety and tolerability are currently being evaluated in a small study that’s scheduled to wrap up late next year.

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