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Denali Therapeutics Announces Initiation of Phase 1/2 Clinical Trial of DNL593 (PTV:PGRN) for Frontotemporal Dementia-Granulin (FTD-GRN)
SOUTH SAN FRANCISCO, Calif., March 09, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad
About this update from Denali Therapeutics Inc.
[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., March 09, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced that dosing has begun in a Phase 1/2 clinical trial of DNL593 (PTV:PGRN) for the potential treatment of frontotemporal dementia (FTD) caused by mutations in the granulin gene (GRN). Pending initial clinical data from the Phase 1 healthy volunteer portion of the clinical trial, Denali expects to begin dosing individuals with FTD-GRN in the second half of 2022. Denali and Takeda have a strategic collaboration to co-develop and co-commercialize DNL593. FTD-GRN is characterized by progranulin (PGRN) deficiency in the brain. DNL593 is an investigational brain-penetrant, recombinant PGRN replacement therapy enabled by Denali’s Protein Transport Vehicle (PTV:PGRN). The therapeutic goal of DNL593 is to slow or prevent progression of FTD-GRN by increasing intracellular and extracellular levels of functional PGRN. “Denali has a diverse portfolio of therapeutic candidates to address neurodegenerative and lysosomal diseases, and DNL593 is our second Transport Vehicle (TV) technology-enabled program to enter clinical development,” said Carole Ho, M.D., Denali’s Chief Medical Officer. “Initiation of this Phase 1/2 trial is an important development milestone for the program, and we look forward to continued collaboration with Takeda and the FTD community in our unified purpose to develop DNL593 as a treatment option for people and families living with FTD-GRN.” “The progression of the DNL593 program into the clinic underscores the potential for Denali’s Protein Transport Vehicle technology to address one of the major challenges we face in neuroscience drug development, namely the ability to effectively deliver drugs to the central nervous system. For DNL593, this means delivering what we believe to be therapeutic levels of recombinant progranulin to the brain and into neurons and glial support cells,” said Sarah Sheikh, BM BCh, MSc, MRCP, Head, Neuroscience Therapeutic Area Unit at Takeda. “Through our collaboration with Denali, we have an opportunity to bring transformative treatments for people living with devastating neurological disorders such as FTD-GRN.” The Ph...