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Denali Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights
SOUTH SAN FRANCISCO, Calif., Aug. 08, 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., Aug. 08, 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 second quarter ended June 30, 2022, and provided business highlights. “The Phase 1 study of DNL919 (ATV:TREM2) is now underway, making this our third BBB Transport Vehicle (TV)-enabled program, and seventh program overall, in clinical development,” said Ryan Watts, Ph.D., Denali's Chief Executive Officer. “Furthermore, advancement of our portfolio to late-stage development was highlighted in the quarter with initiation of late-stage studies for BIIB122 (LRRK2 inhibitor) and SAR443820 (RIPK1 inhibitor) in Parkinson’s disease and ALS, respectively. We also look forward to presenting data from ongoing studies of DNL310 (ETV:IDS) in Hunter syndrome and DNL343 (eIF2B activator) in ALS in the second half of the year.” Second Quarter and Recent Program Updates: Denali-Led Programs DNL310 (ETV:IDS): MPS II (Hunter syndrome) New longer-term interim data from the ongoing Phase 1/2 study will be presented at the 2022 Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium being held in Freiburg, Germany, August 30 – September 2, 2022.Interim data continue to show sustained normalization to healthy levels of CSF heparan sulfate and improvements in markers of lysosomal function consistent with durable CNS activity; safety profile with up to 85 weeks of dosing remains comparable with standard of care therapy.In addition, 49-week open label data on global impression of change continues to suggest stabilization and/or improvement in MPS II symptoms.Denali has initiated recruitment of the Phase 2/3 COMPASS study which will enroll approximately 54 MPS II patients. Upon completion of the ongoing Phase 1/2 study, and together with data from the global COMPASS study, this combined data package will potentially support registration. DNL343 (eIF2B activator): Amyotrophic Lateral Sclerosis (ALS) Denali plans to present data from the ongoing Phase 1b study in ALS in the second half of 2022.Based on Phase 1 data and ongoing blinded Phase 1b data, Denali has initiated planning for late-stage development of DNL343 in ALS. TAK-594/DNL5...