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Ventus Therapeutics Announces First Participant Dosed in Clinical Study with an NLRP3 Inhibitor Licensed Exclusively to Novo Nordisk

WALTHAM, Mass. & MONTREAL — May 3, 2024 — (BUSINESS WIRE) — Ventus Therapeutics, Inc., a clinical-stage biopharmaceutical company utilizing its proprietary structural biology and computational chemistry platform, ReSOLVE™, to develop differentiated small molecule therapeutics, today 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.

“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, Ph.D., 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.

“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.”

About 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-1β 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-1β 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.

About the Partnership
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.

About Ventus Therapeutics
Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying deep protein science expertise and a proprietary computational chemistry platform to develop novel small molecule therapeutics for immunology, inflammation, and neurology disorders. Using its proprietary drug discovery platform, ReSOLVE™, the company 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. For more information, please visit www.ventustx.com and engage with Ventus on LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that may cause Ventus’ actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements.  In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” or “continue” or the negative of these terms or other similar expressions. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the timing, progress, and results of the Phase 1 clinical study for NNC6022-0001, the potential therapeutic applications of NLRP3, and the timing and likelihood of the achievement of milestones pursuant to our existing development and licensing agreement. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond Ventus’ control, you should not rely on these forward-looking statements as predictions of future events. Such risks include, but are not limited to, the risk that Ventus is unable to further advance VENT-02 and VENT-03 in clinical development, obtain regulatory approval, and ultimately commercialize VENT-02 and VENT-03, or experience significant delays in doing so; that Ventus will require substantial additional funding to finance its operations; that the development and commercialization of pharmaceutical products is subject to extensive regulation, and the regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign authorities are lengthy, time-consuming, and inherently unpredictable; and that Ventus’ success depends on its, its current and future licensors’, and its exclusive licensees’ ability to obtain, maintain, enforce, and protect its intellectual property and its proprietary technologies. Forward-looking statements included herein are based upon information available to Ventus as of the date of this press release, and while Ventus believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and Ventus’ statements should not be read to indicate that it has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Ventus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise.

Media Contact
Dan Budwick