Denali Therapeutics Provides Pipeline and Business Update in Response to the COVID-19 Pandemic

SOUTH SAN FRANCISCO, Calif., April 02, 2020 (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 provided an update on the expected pipeline and business impact from the COVID-19 pandemic.

“In these unprecedented times, our resolve to defeat degeneration is undiminished and our top priority is to ensure the health and safety of our employees, community, partners and clinical trial participants,” said Ryan Watts, Ph.D., CEO. “We are very pleased with our productivity under the circumstances and we continue to generate and analyze new data across our pipeline. We are, however, experiencing enrollment delays in some of our clinical stage programs, and consequently we are actively working to maintain clinical operations to minimize any disruption.”

Clinical trials and business update

• LRRK2 program for Parkinson’s disease: the DNL201 Phase 1b trial is completed and positive results were recently presented. For the ongoing DNL151 Phase 1 and Phase 1b trials, enrollment of additional healthy volunteers and patients at higher doses has been paused due to the COVID-19 pandemic. Denali is analyzing available data from these trials and is on track to select either DNL201 or DNL151 by mid-2020 to progress into Phase 2/3 trials.
  
  
• ETV:IDS program for Hunter Syndrome: Denali continues to collect data from patients enrolled in the ongoing observational biomarker study. However, recruitment of additional patients has been paused due to the COVID-19 pandemic. The DNL310 Phase 1/2 trial is on track to commence in Q2 2020.
   
• RIPK1 program for Alzheimer’s disease and ALS: the DNL747 Phase 1b trials are fully enrolled and have completed dosing for the primary analysis. In addition, Denali continues to collect data from the ongoing Phase 1b open-label extension study in ALS. Analysis of data from these trials is underway and Denali is on track to decide on next steps with DNL747 by mid-2020 together with its partner Sanofi.
  
  
• EIF2B program for ALS: the DNL343 Phase 1 trial in healthy volunteers is ongoing and dosing is completed for a portion of the study. Enrollment of additional subjects has been paused due to the COVID-19 pandemic and this could lead to a delay in the completion of the study.
  

Denali has drug supplies to complete ongoing trials as well as additional drug substance supplies expected to be sufficient to support planned clinical trials well into 2021. Denali currently does not expect delays to its clinical trials due to manufacturing or supply-chain issues.