June 8, 2023 Source: drugdu 148
Nicole DeFeudis
Editor
Biogen is calling it quits on a late-stage Parkinson’s trial as part of an ongoing R&D reorganization.
The Cambridge, MA-based biotech announced Monday morning that it’s discontinuing a Phase III program evaluating BIIB122 as a treatment for patients with Parkinson’s disease related to LRRK2 mutations with partner Denali Therapeutics. The study, dubbed LIGHTHOUSE, kicked off in September; it was slated for completion in 2031. Biogen said the decision was made in consideration of the study’s “complexity including the long timeline.”
“These modifications are not based on any safety or efficacy data from studies of BIIB122,” the company said in a statement. “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.”
Back in 2020, Biogen shelled out more than $1 billion upfront — including $560 million in cash and $465 million in equity — to work with Denali primarily on a Parkinson’s program targeting the LRRK2 gene, mutations of which are associated with rare familial forms of the disease. The LRRK2 program has milestones that total up to $1.1 billion.
Biogen and Denali said they are now focusing their efforts on the ongoing Phase IIb LUMA study in patients with early-stage Parkinson’s. This trial will now also enroll patients with a LRRK2 mutation in addition to the previously eligible trial population, and patients enrolled in the LIGHTHOUSE study will be given the chance to join the LUMA study.
The news comes a month after Biogen revealed plans to scrap three other clinical programs as well as deprioritize preclinical gene therapy and ophthalmology programs. This is part of a larger R&D overhaul under CEO Chris Viehbacher, who joined the company in November to right the ship after fallout from the controversial Alzheimer’s drug Aduhelm. The company has since won accelerated approval for its Eisai-partnered Alzheimer’s drug Leqembi and is seeking a full approval of the drug.
Biogen has said it’s looking to diversify its pipeline away from high-risk neurological drugs and hinted at M&A plans earlier this year.
“The tide going out on MS and the tide coming in on new products,” Viehbacher said during the first-quarter earnings call. “We obviously have a lever with cost that we can use, but external growth could also help us to manage that transition period.”
Reference: https://endpts.com/
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