Biogen and Denali Realign Parkinson's Disease Research Priorities Amidst R&D Restructure

  • In its ongoing R&D reorganization, Biogen Inc BIIB will discontinue a Phase 3 program evaluating BIIB122 as a treatment for patients with Parkinson’s disease related to LRRK2 mutations with partner Denali Therapeutics Inc DNLI.
  • Before the planned revisions, the BIIB122 development program encompassed the following:
    • The Phase 2b LUMA study in participants with early-stage Parkinson’s disease commenced in May 2022. 
    • The Phase 3 LIGHTHOUSE study in participants with Parkinson’s disease related to LRRK2 mutations commenced in September 2022 and was slated for completion in 2031. Biogen said the decision was made considering the study’s “complexity, including the long timeline.”
  • Related: Biogen Announces Additional Cost Cutting Initiatives, Chops Certain Stroke, Gene Therapy Programs.
  • “These modifications are not based on any safety or efficacy data from studies of BIIB122,” the company said. “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.”
  • Biogen and Denali said they are now focusing on the ongoing Phase 2b LUMA study in patients with early-stage Parkinson’s. 
  • This trial will now also enroll patients with an LRRK2 mutation in addition to the previously eligible trial population, and patients enrolled in the LIGHTHOUSE study will be given a chance to join the LUMA study.
  • In August 2020, Biogen and Denali signed a binding agreement to co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s disease.
  • Biogen shelled out $560 million and $465 million equity investment.
  • Price Action: DNLI shares closed down 3.36% at $30.46 on Monday.
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