Shots:
- Biogen has reported the global P-II (CELIA) trial data assessing diranersen [60mg (Q24W), 115mg (Q24W), or 115mg (Q12W); intrathecal) vs PBO over 76wks. in 416 pts with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia
- Although CELIA did not meet its 1EP of dose response on CDR-SB change from baseline at wk. 76, pre-specified analyses showed slowing of clinical decline across all diranersen doses, especially 60mg (Q24W), alongside sustained reductions in CSF tau & tau pathology on PET imaging throughout treatment; data to be presented at AAIC’26
- Based on the strength of the biomarker and efficacy data, Biogen intends to progress diranersen into registrational-stage development
Ref: Biogen | Image: Biogen |Press Release
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