DNL-126 is under clinical development by Denali Therapeutics and currently in Phase II for Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome ). According to GlobalData, Phase II drugs for Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome ) does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the DNL-126 LoA Report. Buy the report here.

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-126 overview

DNL-126 is under development for the treatment of mucopolysaccharidosis III (Sanfilippo Syndrome). It is administered through intravenous route. The drug candidate comprises of recombinant SGSH enzyme engineered to cross the blood-brain barrier. It acts by targeting sulphamidase and is developed based on enzyme transport vehicle (ETV) platform.

Denali Therapeutics overview

Denali Therapeutics (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 operates in the UK and the US. Denali Therapeutics is headquartered in San Francisco, California, the US.

For a complete picture of DNL-126’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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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.