Citing adverse findings from primate toxicity studies, Denali Therapeutics (NASDAQ:DNLI), together with collaboration partner Sanofi (NASDAQ:SNY),
has decided to halt Phase 1b clinical trials evaluating RIPK1 inhibitor
DNL747 in Alzheimer’s disease and ALS and focus its resources on
accelerating development of DNL788 which, it says, has superior drug
properties.
Studies in cynomolgus monkeys showed dose- and
duration-dependent adverse findings at exposures higher than those
testing in the clinic. The findings, considered off-target and
molecule-specific, impact the ability to increase the dose without
additional time-consuming safety studies.
RIPK1 (receptor-interacting
serine/threonine-protein kinase 1) is a critical signaling protein in
the TNF receptor pathway which regulates inflammation and cell death.
https://seekingalpha.com/news/3581726-denali-pivots-on-neuro-candidate-on-safety-signals
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