Biogen has disclosed plans to stop a late-stage clinical trial testing one of its drugs as a potential treatment for Parkinson’s disease.
According to a Monday announcement, the decision is due to several factors, including the trial’s complexity and run time. Results weren’t expected to come in until early 2031. Another, ongoing study evaluating the drug in early Parkinson’s patients will continue, with its protocol amended to allow eligible participants from the discontinued trial to enroll.
Biogen and its development partner, Denali Therapeutics, noted how these changes aren’t related to the safety or effectiveness of their drug, which is named BIIB122. Rather, the companies agreed that what’s best for the BIIB122 program is to get a “timely readout” in early-stage Parkinson's, while also collecting additional data.
Denali and Biogen say they “remain committed to advancing the development of BIIB122.”
The trial slated for discontinuation focuses specifically on patients with mutations in a gene known as LRRK2. Such mutations have been tied to Parkinson’s, and while estimates vary, researchers believe they’re behind roughly 4-13% of cases where the disease is inherited and 1-5% of cases where it arises sporadically. Biogen’s trial dosed its first patients last fall, and aimed to recruit around 400 participants altogether.
Approximately half a million people in the U.S. are known to have Parkinson’s, according to the National Institutes of Health, although the agency acknowledges the actual number is likely much higher because many patients are undiagnosed or misdiagnosed. There is currently no cure for the disease, though there are medications, like levodopa, that can help alleviate symptoms.
The revised plan for BIIB122 is the latest example of a research overhaul that’s taken place at Biogen over the last several months. Under new CEO Christopher Viehbacher, the company has been branching out from its core area of neuroscience, where drug development often requires long, large and expensive clinical trials. Biogen executives have said they’re looking to invest more into immunology, rare diseases and neuropsychiatry.
At the same time, they’ve also made cuts to existing research programs. The company scrapped at least four experimental drugs so far this year, including ones targeting pain, multiple sclerosis and a severe kind of stroke. At least three other drugs were shelved last year.
On a recent earnings call, Biogen executives also disclosed that the company would be exiting research related to eye diseases and “refocusing” its investments in gene therapy.
The company is “looking at every program in great depth, several times over, and thinking about what are the options, what are the operational and strategic and regulatory challenges, but also the opportunities,” Priya Singhal, Biogen’s head of development and interim head of research, said during that call.
Over the course of last year, Biogen spent more than $2.2 billion on research and development. Meanwhile, the company recorded a 7% decline in annual revenue from 2021, as market competition continued to eat away at its top-selling products, which treat multiple sclerosis and a rare disorder called spinal muscular atrophy.