Denali Therapeutics Expected Key Milestones in 2021

 

• Late-breaker presentation on 12-week data from Cohort A in Phase 1/2 study of DNL310 (ETV:IDS) in Hunter syndrome (MPS II) to be held at WORLD Symposium on February 12th
  
• Following previously announced data on CSF GAG reduction with DNL310 and achievement of biomarker proof-of-concept, Phase 1/2 study is expanded with the addition of a third cohort (Cohort C) to further explore clinical endpoints
• Announcing five new enzyme replacement therapy programs in Transport Vehicle (TV) portfolio; expanding manufacturing capabilities and building out commercial capabilities
• Phase 1b study of LRRK2 inhibitor, DNL151 (BIIB122), in Parkinson’s disease is complete; target engagement and pathway engagement goals were met and data will be presented at an upcoming medical congress; late-stage clinical development to begin by year-end 2021 in collaboration with Biogen
• Phase 1 healthy subject data on EIF2B activator, DNL343, expected to be available in 1H 2021; Phase 1b study in ALS patients planned to begin in 2H 2021​
• Phase 1 study of CNS-penetrant RIPK1 inhibitor, DNL788 (SAR443820), initiated by Sanofi in Q4 2020; Phase 2 study of peripherally-restricted RIPK1 inhibitor, DNL758 (SAR443122), in cutaneous lupus erythematosus to begin in early 2021
• IND-enabling studies for PTV:PRGN and ATV:TREM2 to trigger two milestone payments from Takeda in Q1 2021

https://www.globenewswire.com/news-release/2021/01/08/2155565/0/en/Denali-Therapeutics-Announces-Significant-Program-Progress-and-Expected-Key-Milestones-in-2021-for-Its-Broad-Therapeutic-Portfolio-in-Neurodegeneration.html