Lilly and Rigel to develop RIPK1 inhibitors for immunological, neurodegenerative diseases

Eli Lilly and Rigel Pharmaceuticals has forged a license agreement and strategic collaboration to co-develop and commercialise the latter’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases.

Pursuant to the collaboration, Lilly will also lead all clinical development of brain penetrating RIPK1 inhibitors in central nervous system (CNS) diseases.

Rigel’s lead RIPK1 inhibitor, R552, has completed Phase 1 clinical trials and will begin Phase 2 clinical trials in 2021 as part of the collaboration. Rigel also has ongoing pre-clinical activities with its lead CNS penetrant RIPK1 inhibitor candidates.

Lilly will pay an upfront cash payment to Rigel of $125 million. Rigel may also be eligible to receive up to $835 million in potential development, regulatory, and commercial milestone payments, as well as tiered royalties ranging from the mid-single digit to high-teens that will vary depending upon Rigel’s clinical development investment.

Lilly and Rigel will co-develop R552 at specified contribution levels. Lilly will be responsible for all costs of global commercialisation for R552, and Rigel will have the right to co-commercialise R552 in the US Lilly will be solely responsible for all clinical development and commercialisation of brain penetrating RIPK1 inhibitors in CNS indications.

RIPK1 is a critical signalling protein implicated in a broad range of key inflammatory cellular processes including necroptosis, a type of regulated cell death, and cytokine production. In necroptosis, cells rupture leading to the dispersion of cell contents which can trigger an immune response and enhance inflammation.

Inhibiting RIPK1 may be a new approach to treating various autoimmune, inflammatory, and neurodegenerative disorders. In pre-clinical studies, Rigel’s R552 demonstrated prevention of joint and skin inflammation in a RIPK1-mediated murine model of inflammation and tissue damage.

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