Business
Denali Therapeutics Reports First Quarter 2023 Financial Results and Business Highlights
SOUTH SAN FRANCISCO, Calif., May 08, 2023 (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., May 08, 2023 (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 the treatment of neurodegenerative diseases and lysosomal storage diseases, today reported financial results for the first quarter ended March 31, 2023, and provided business highlights. “In the first quarter, we continued to make significant progress across our broad therapeutic portfolio, including the advancement of multiple late-stage programs,” said Ryan Watts, Ph.D., Chief Executive Officer at Denali. “As the global Phase 2/3 COMPASS study of DNL310 (ETV:IDS) enrolls children with MPS II, we were excited to share new interim, open-label Phase 1/2 data demonstrating positive changes in behavioral and cognitive aspects of the disease that are particularly important to MPS II families and data suggesting additional peripheral activity in children who switched from standard of care. In addition, at the recent AAN meeting, we reported positive biomarker and safety data from the 28-day Phase 1b study of our eIF2B agonist, DNL343, and we are eager to learn more about the potential of DNL343 from its planned inclusion in the Phase 2/3 HEALEY Platform Trial. We look forward to continued collaboration with individuals, families, and communities impacted by neurodegenerative and lysosomal storage diseases as we strive to discover, develop, and deliver safe and effective new medicines.” First Quarter and Recent Program Updates: TV-ENABLED PROGRAMS DNL310 (ETV:IDS): MPS II (Hunter syndrome) DNL310 is an investigational, intravenously administered, Enzyme Transport Vehicle (ETV)-enabled, brain-penetrant iduronate-2-sulfatase (IDS) replacement therapy designed to address the behavioral, cognitive and physical manifestations of MPS II (Hunter syndrome). In February, Denali reported new interim results at the WORLDSymposiumTM from the ongoing open-label, single-arm Phase 1/2 study of DNL310 in children with MPS II, including data from additional participants and up to 104 weeks of treatment. Over 49 weeks of DNL310 treatment, positive changes across measures of exploratory clinical outcomes including VABS-II (adaptive behavior) and BSID-III (cognitive capabilities) scores and global impression scales were ob...