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.
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Dan Budwick 1AB dan@1abmedia.com