After making a research agreement with Mervus NV and Asahi Kasei Pharma, Lilly has entered the third collaboration this year with Rigel Therapeutics to co-develop molecules developed for inflammatory disorders and neurodegeneration. The deal is centered on an experimental med R552 and its brain penetrating versions that inhibit receptor-interacting serine/threonine-protein kinase 1 (RIPK1). Rigel’s shares jumped 23% premarket following the news and are currently trading at an almost 8-year high of $5.50.
Lilly is entering the deal at a time when the lead candidate is set to enter Phase 2 trial and a set of other CNS penetrant RIPK1 inhibitor candidates are in preclinical testing. For this slate of drugs, Rigel will receive $125 million in upfront payment and is eligible to receive as much as $835 million in milestone payments, plus royalties.
Lilly already has an impressive portfolio of marketed inflammatory drugs, such as Olumiant for rheumatoid arthritis and a blockbuster drug, Taltz, which is approved to treat diseases like plaque psoriasis and psoriatic arthritis. Besides that, it has several experimental treatments for eczema, ulcerative colitis, psoriasis, and Crohn’s disease. The deal with Rigel will further strengthen its autoimmune portfolio. It’s like a cherry on top of the cake.
“At Lilly, our immunology strategy is focused on the pursuit of novel targets that have the potential to develop into best-in-class medicines for patients with autoimmune conditions,” said Ajay Nirula, M.D., Ph.D., Vice President of immunology at Lilly. “RIPK1 inhibitors are a promising approach, and R552 is an exciting addition to our immunology pipeline. We look forward to working with Rigel to advance its clinical development.”
Terms of the Agreement
The two have divided their jobs for the efficient and speedy development of the drug. “Lilly and Rigel will co-develop R552 at specified contribution levels,” according to a statement. Lilly will look after costs of global commercialization for R552, and Rigel will have the right to co-commercialize R552 in the US. As for the brain penetrant RIPK1 inhibitors, Lilly will solely be responsible for clinical development and commercialization of those in CNS indications.
Early Days for RIPK1 Inhibitors
RIPK1 inhibitors essentially stop the function of an enzyme that plays an important role in inflammation and cell death. Under normal conditions, RIPK1 levels are kept under check by a set of enzymes that cleave any unwanted protein. Under inflammatory conditions, this balance tips on the other side, increasing the concentration of RIPK1 in the cells. This results in uncontrolled cell death and inflammation.
The interest in this target is very new and very few are working in this field. Denali and Sanofi inked a $125 million deal in 2018 for developing two RIPK1 inhibitors, designed to treat multiple neurodegenerative and systemic inflammatory diseases. But last year, the two paused their trial with their RIPK1 inhibitor after it failed to show any improvement in Alzheimer’s disease and amyotrophic lateral sclerosis. Nevertheless, the duo is hopeful and is expected to begin another clinical trial this year with their RIPK1 drug.
Rigel’s drug showed positive results in preclinical trials. It prevented joint and skin inflammation in a RIPK1-mediated rodent model of inflammation and tissue damage. It has cleared Phase 1 testing and is now heading towards Phase 2 trial. The pair is confident about their drug and is hoping to see the same results as the preclinical study in the Phase 2 trial. If successful, the drug could capture a big chunk of a market that is projected to reach $153,320 million by 2025.
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