The deal, valued at more than $1 billion, will support the development of neurological and systemic inflammatory disease treatments.
Denali Therapeutics is a biotech company focused on applying recent advances in genetics, biology and translational medicine to the discovery and development of effective medicines for patients suffering from neurodegenerative diseases. In particular, the company is focused on developing targets that modulate disease pathways involving degenogenes, genes that cause or are major risk factors for neurodegenerative disease when mutated.
The progress at Denali has attracted the attention of Sanofi, which recently entered into a collaboration with the company. The partners will develop several molecules with the potential to serve as treatments for neurological and systemic inflammatory diseases. Denali will receive $125 million in upfront payments from Sanofi and has the potential to earn milestone payments worth more than $1 billion. The two companies will share any commercial profits and losses relating to DNL747 in the US and China. Denali will receive royalty payments on sales of any DNL747 drugs commercialized in other parts of the world.
The two leading candidates are DNL747 and DNL758. These compounds are designed to target the receptor-interacting serine/threonine-protein kinase 1 (RIPK1) in the TNF receptor pathway associated with inflammation and cell death.
The partners will investigate the safety and efficacy of DNL747 (currently in Phase I clinical trials, with a Phase 2b trial planned in Alzheimer’s or ALS) in multiple sclerosis (MS), Alzheimer’s disease and amyotrophic lateral sclerosis (ALS) and DNL758 (set to enter clinical trials in 2019) in systemic inflammatory diseases such as rheumatoid arthritis.
Denali’s responsibility for DNL747 will be to conduct phase 2 Alzheimer studies. Sanofi will be responsible for phase 2 trials of DNL747 in MS and ALS and any future phase 3 trials. Sanofi will manage all trials with DNL758 in systemic inflammatory diseases.