Denali Therapeutics (NASDAQ: DNLI) has announced disappointing results from a Phase II trial of its RIPK1-targeted small-molecule drug for amyotrophic lateral sclerosis (ALS). The drug, developed in partnership with France-based Sanofi Inc. (NASDAQ: SNY), failed to meet the primary endpoint in the Phase II HIMALAYA study, which assessed the change in the ALS Functional Rating Scale-Revised (ALSFRS-R).
According to a recent SEC filing, Sanofi, responsible for the drug’s development, will provide a comprehensive data breakdown at an upcoming scientific forum. The RIPK1 signaling protein is believed to play a crucial role in inflammation and cell death, which initially attracted Sanofi to collaborate with Denali in 2018, resulting in a $125 million upfront payment and commitments exceeding $1 billion in potential milestone payments. While the development of DNL788 for ALS will be discontinued, a Phase II trial for multiple sclerosis (MS) remains ongoing, and Denali and Sanofi continue to advance DNL310 for Hunter syndrome.- Flcube.com
