• 08 May 2024
• Admin
• News Article

Ventus Collabs with Novo Nordisk Starts Phase 1 Clinical Study for NNC6022-0001

Ventus Therapeutics’ partner Novo Nordisk doses first participant in phase 1 clinical study for NNC6022-0001, an oral NLRP3 inhibitor

Overview

Ventus Therapeutics, Inc, a clinical-stage biopharmaceutical company utilizing its proprietary structural biology and computational chemistry platform, ReSOLVE, to develop differentiated small molecule therapeutics, 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.

Words from Novo Nordisk

• “NLRP3 inhibitors have potential in a wide variety of cardiometabolic diseases, including obesity, metabolic dysfunction-associated steatohepatitis (MASH), and chronic kidney disease. Since the beginning of our partnership with Ventus, we have seen additional evidence for the broad range of opportunities addressable by targeting NLRP3,” said Karin Conde-Knape, senior vice president of global drug discovery at Novo Nordisk. 
• “This trial initiation marks the first stage in our NLRP3 inhibitor clinical program, and we are eager to be a key player in this expanding field.”

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.

Words from CSO: 

• “Since the founding of Ventus, we have been focused on the structure and potential of NLRP3 based on its wide-ranging application across multiple therapeutic areas,” said Ventus chief scientific officer, Michael Crackower, Ph.D. 
• “We have had a great working relationship with Novo Nordisk since the establishment of our collaboration, and we are very pleased that our partner has reached this clinical milestone, marking the third Ventus-discovered compound to enter the clinic in the last nine months.”

NLRP3

• 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.

Exclusive Worldwide Rights

• 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.

Using ReSOLVE

• Using its proprietary drug discovery platform, ReSOLVE, Ventus screened its first target in 2020, selected three development candidates in 2022, and advanced its two wholly-owned product candidates into the clinic in 2023: VENT-03, a potent, selective, oral cGAS inhibitor in phase 1, and VENT-02, a potent, brain-penetrant, oral NLRP3 inhibitor that has completed phase 1.
• In addition, Ventus has out-licensed VENT-01, a peripherally-restricted NLRP3 inhibitor, to Novo Nordisk A/S. 
• These programs exemplify Ventus’ robust discovery capabilities and focus on differentiated programs for multi-indication immunology and neurology targets.