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Denali Therapeutics Provides Broad Update on Its RIPK1 Program Partnered With Sanofi
Denali and Sanofi pause DNL747(a) clinical activities based on the totality of DNL747 data and a superior profile of backup compound DNL788(b)Denali and
About this update from Denali Therapeutics Inc.
[{"type":"text","content":"Denali and Sanofi pause DNL747(a) clinical activities based on the totality of DNL747 data and a superior profile of backup compound DNL788(b)Denali and Sanofi intend to accelerate DNL788 for development in neurological indications, with plans to initiate clinical testing by early 2021Safety endpoints were met in Phase 1b patient studies with DNL747 in ALS and Alzheimer’s disease, however further dose escalation to achieve higher levels of target inhibition may be limited by preclinical chronic safety dataSanofi successfully completed the Phase 1 healthy volunteer study with peripherally-restricted RIPK1 inhibitor DNL758(c), and further clinical studies in multiple indications are being planned SOUTH SAN FRANCISCO, June 09, 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 announced the results from its Phase 1b studies with small molecule RIPK1 inhibitor DNL747 in Alzheimer’s disease and ALS, and provided a broad RIPK1 program update including DNL788 and DNL758.\n “Together with our partner Sanofi, we have decided to pause clinical studies with DNL747 and focus our efforts on accelerating development of DNL788, which we believe has superior drug properties and a more rapid path toward proof-of-concept clinical studies in patients in multiple neurological indications,\" said Ryan Watts, Ph.D., CEO. “We’d like to thank all patients who took part in these studies. Your participation is critical in the ultimate success of developing medicines for these terrible diseases.” RIPK1, receptor-interacting serine/threonine-protein kinase 1, is a critical signaling protein in the TNF receptor pathway, which regulates inflammation and cell death in tissues throughout the body. Data from 31 patients in two 29-day Phase 1b studies in Alzheimer’s disease and ALS, and additional data from six ALS patients in an open label extension study, showed that DNL747 was safe and well tolerated at the dose tested with no significant treatment related adverse events. Target engagement of approximately 80% median inhibition of pRIPK1 in blood at trough drug concentration was achieved. In parallel to the clinical studies, chronic toxicity studies with DNL747 in cynomolgus mon...