Business
Denali Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Business Highlights
SOUTH SAN FRANCISCO, Calif., Feb. 28, 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., Feb. 28, 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 reported financial results for the fourth quarter and year ended December 31, 2021, and provided business highlights. “Denali is now transitioning to a late-stage development company, having made significant progress in advancing our clinical portfolio of product candidates for neurodegenerative and lysosomal storage diseases during 2021,” said Ryan Watts, Ph.D., Denali’s Chief Executive Officer. “In 2022, we plan to advance DNL151 and DNL310 into potentially registrational clinical trials for Parkinson’s disease and MPS II (Hunter syndrome), respectively, as well as DNL788 into a Phase 2 trial for ALS. We are advancing new Transport Vehicle (TV) programs into the clinic, starting with DNL593 (PTV:PGRN) for FTD-GRN. In addition, we also look forward to generating initial clinical data with our novel eIF2B activator, DNL343, in ALS.” Recent Program Highlights and Expected Milestones BIIB122/DNL151 (LRRK2 inhibitor): Parkinson’s disease (idiopathic and LRRK2-positive) Announced details on study designs for two late-stage clinical trials of BIIB122/DNL151 in Parkinson’s disease (PD). The LUMA Study is a global Phase 2b trial expected to enroll approximately 640 participants with PD who do not carry a LRRK2 mutation and is designed to potentially support registration of BIIB122. The LIGHTHOUSE Study is a global Phase 3 trial expected to enroll approximately 400 PD participants with LRRK2 mutations.Denali’s collaborator Biogen is leading the execution of both the LUMA and LIGHTHOUSE clinical trials for which dosing is expected to begin in 2022. DNL310 (ETV:IDS): MPS II (Hunter syndrome) Presented interim data from the Phase 1/2 clinical trial of DNL310 at the WORLDSymposium™ on lysosomal diseases. Longer-term data in 20 patients with MPS II continued to show sustained normalization of CSF heparan sulfate, consistent with durable CNS activity, with up to one year of intravenous dosing with DNL310. DNL310 remained generally well tolerated with a safety profile consistent with standard-of-care enzyme replacement therapy.Also at the WORLDSymposium™ conference, presented d...