Ventus Therapeutics, Inc. announced that its partner, Novo Nordisk, has successfully dosed the first participant in a Phase 1 clinical study for NNC6022-0001 (formerly known as VENT-01) - an oral NLRP3 inhibitor licensed by Novo Nordisk in September 2022. The Phase 1 study is designed to fully explore the pharmacokinetics, pharmacodynamics, and safety of NNC6022-0001 across a broad range of doses in healthy volunteers. NLRP3 is the best understood member of a family of proteins known as inflammasomes.

Inflammasomes are multiprotein complexes that regulate the innate immune system and are involved in intracellular surveillance of danger and pathogen signals that trigger an intense inflammatory response, including the release of IL-1ß and IL-18 and the induction of pyroptosis, an inflammatory form of cell death. Therapeutic inhibition of NLRP3 can prevent the formation of the NLRP3 inflammasome, which in turn inhibits the production of IL-1ß and IL-18 as well as pyroptosis. Aberrant activation of the NLRP3 inflammasome has been associated with systemic conditions, including fibrotic, dermatological, and rheumatological diseases, and is a key driver of disease pathology in several neurological disorders, including Parkinson?s disease, Alzheimer?s disease, and treatment-refractory epilepsy.

In September 2022, Ventus and Novo Nordisk announced an exclusive development and licensing agreement where Novo Nordisk gained exclusive worldwide rights to develop and commercialize Ventus? lead NLRP3 inhibitor program for a broad range of diseases, including metabolic dysfunction-associated nonalcoholic steatohepatitis (MASH), chronic kidney disease, and other cardiometabolic conditions. Ventus received an upfront payment of $70 million and ongoing research and development funding, and is eligible to receive up to an additional $633 million in potential clinical, regulatory, and commercial milestones as well as tiered royalties.