Drugmakers Biogen and Denali Therapeutics said they will discontinue development of BIIB122 for idiopathic Parkinson’s disease after the drug failed to meet primary and secondary endpoints in a phase 2b study.
The phase 2b Luma study evaluated BIIB122, an investigational LRRK2 inhibitor, in 648 people with early stage Parkinson’s disease between the ages of 30 and 80, according to a May 21 Biogen news release. Participants received the therapy or placebo for a minimum of 48 weeks and up to 144 weeks.
The companies said BIIB122 did not slow disease progression compared to placebo as measured by changes in Movement Disorder Society Unified Parkinson’s Disease Rating Scale scores. Secondary endpoints also showed no benefit.
The failure marks a significant blow to one of the most closely watched drug candidates in Parkinson’s research. The breadth of investment in BIIB122 signaled just how much the field had riding on it. In 2020, Biogen paid $560 million up front and made a $465 million equity investment in Denali to license the program, with Denali eligible for up to $1.125 billion more in milestone payments. The drug drew that kind of investment because it targeted something no approved Parkinson’s therapy has ever achieved: slowing disease progression rather than just managing symptoms.
Denali said it will continue independently conducting the phase 2a Beacon study in patients carrying a pathogenic LRRK2 variant. Data from that study is expected in the first half of 2027, the release said.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
