Denali Therapeutics Announces Completion of Enrollment for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial

SOUTH SAN FRANCISCO, Calif., May 01, 2024 (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 and lysosomal storage diseases, today announced that the Sean M. Healey & AMG Center in collaboration with the Northeast ALS Consortium (NEALS) completed enrollment for Regimen G of the Phase 2/3 HEALEY ALS Platform Trial, which evaluates Denali’s eIF2B agonist DNL343.

“We are excited to move to the next phase of Regimen G and evaluate the effects of DNL343,” said Merit Cudkowicz, MD, MSc, principal investigator and sponsor of the HEALEY ALS Platform Trial, director of the Sean M. Healey & AMG Center for ALS, chair of the Department of Neurology at MGH, and the Julieanne Dorn Professor of Neurology at Harvard Medical School. “We are grateful for the continued support of the ALS community and look forward to sharing the results.”

Regimen G is co-led by Suma Babu, MBBS, MPH, and Sabrina Paganoni, MD, PhD, physician investigators at the Healey & AMG Center for ALS at MGH.

“The conclusion of enrollment for Regimen G marks a critical step forward for the HEALEY ALS platform Trial,” said Drs. Paganoni and Babu. “We extend our thanks to Denali, academic collaborators, and benefactors of the trial as we move to the next stage.”