DNL-343 is under clinical development by Denali Therapeutics and currently in Phase III for Amyotrophic Lateral Sclerosis. According to GlobalData, Phase III drugs for Amyotrophic Lateral Sclerosis have a 32% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how DNL-343’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
DNL-343 overview
DNL-343 is under development for the treatment of Amyotrophic lateral sclerosis (ALS) and Frontotemporal dementia (FTD). The drug candidate acts by targeting eukaryotic translation initiation factor 2 subunit beta (EIF2B). It is administered through oral route.
Denali Therapeutics overview
Denali Therapeutics is a clinical-stage biopharmaceutical company that focuses on the development of therapeutics for the treatment of neurodegenerative diseases. Its proprietary drug delivery platform technologies include an antibody transport vehicle and an enzyme transport vehicle designed to deliver large molecules across the blood-brain barrier (BBB). Its pipeline products are intended for the treatment of Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease, multiple system atrophy, lysosomal storage disorder MPS II, neurodegeneration, amyotrophic lateral sclerosis and other indications. The company’s product pipeline include DNL201, DNL151, ATV:aSyn, for Parkinson’s disease, DNL747, ATV:Tau, ATV:TREM2, for Alzheimer’s disease; and CH1 and LF1, for neurodegeneration. It has development and commercialization rights to all of its programs, including the programs partnered with Takeda. The company has operates in the UK and the US. Denali Therapeutics is headquartered in San Francisco, California, the US.
For a complete picture of DNL-343’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
