Sanofi has sealed the deal with Denali Therapeutics to leverage the latter’s small molecule candidates in the development of new therapies to tackle a variety of neurological and systemic inflammatory diseases, forging a partnership which could prove to be worth in excess of $1.125 billion.

The total value of the deal breaks down into an initial upfront cash payment of $125 million, and potentially more than $1 billion in future development and commercial milestones.

The pair will work to develop two lead molecules from Denali, known as DNL747 and DNL758, both of which target the receptor-interacting serine/threonine-protein kinase 1 (RIPK1) in the TNF receptor pathway, a key signalling protein responsible for regulating inflammation and cell death.

The plan is to explore the efficacy of DNL747 in multiple sclerosis (MS), Alzheimer's disease, and amyotrophic lateral sclerosis (ALS), while DNL758 will be applied in systemic inflammatory diseases like rheumatoid arthritis and psoriasis.

"RIPK1 is a promising target with the potential to bring disease modifying medicines to patients suffering from neurodegenerative diseases as well as systemic inflammatory diseases. We are very excited to partner with Sanofi and expand our RIPK1 program into new indications," commented Dr Ryan Watts, CEO of Denali. "With its considerable infrastructure and experience in both clinical development and commercial functions, Sanofi is an ideal partner for Denali to maximise the clinical and commercial success of our RIPK1 programme."

Under the terms of the partnership, Sanofi will fund Phase 1b and 2 clinical development for DNL747 in MS, ALS and other neurological conditions with the exception of Alzheimer’s disease, which will be covered by Denali.  Phase 3 trials will be covered 70/30 with Sanofi paying the larger share. The pair will share all commercial profits and losses for the candidate in the US and China, and Denali will receive royalties for other territories. For DNL758, Sanofi will fully cover development costs.

"This collaboration with Denali is yet another example of Sanofi's commitment to accelerate the development of transformative and best-in-class treatments for patients living with serious illnesses," remarked Dr Rita Balice-Gordon, Global Head of Rare and Neurologic Diseases Research at Sanofi. "We look forward to working with Denali on the RIPK1 programme as we explore the potential of this mechanism in neurologic and inflammatory diseases."

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