Verve to Present Interim Data from the heart-1 Phase 1b Clinical Trial of VERVE-101 in HeFH Patients at the American Heart Association’s Scientific Sessions 2023
26 Settembre 2023 - 12:30PM
Verve Therapeutics, a clinical-stage biotechnology company
pioneering a new approach to the care of cardiovascular disease
with single-course gene editing medicines, today announced that the
company will present interim data from its ongoing heart-1 Phase 1b
clinical trial of VERVE-101 for patients with high-risk
heterozygous familial hypercholesterolemia (HeFH) in a
late-breaking science presentation at the American Heart
Association’s (AHA) Scientific Sessions 2023 being held in
Philadelphia from November 11-13.
VERVE-101 is an investigational, in vivo base editing medicine
designed to be a single-course treatment that inactivates
the PCSK9 gene in the liver to durably reduce
disease-driving low-density lipoprotein cholesterol (LDL-C).
VERVE-101 is being developed initially as a treatment for patients
with HeFH, a prevalent and potentially life-threatening genetic
cardiovascular disorder that causes life-long severely elevated
LDL-C, leading to increased risk of early-onset atherosclerotic
cardiovascular disease (ASCVD).
heart-1 is a Phase 1b clinical trial designed to evaluate the
safety and tolerability of VERVE-101 in single ascending dose (SAD)
cohorts of the highest risk patients with HeFH, established ASCVD,
and uncontrolled LDL-C levels on oral standard-of-care therapy. In
addition, the clinical trial is designed to measure PCSK9 protein
and LDL-C changes in patients and assess the potential for early
proof-of-concept of the ability to base edit in the liver.
At AHA, Verve expects to report initial safety and
pharmacodynamic data, as well as blood PCSK9 and blood LDL-C
levels, from patients across four SAD cohorts.
Details of the late-breaking science session are as follows:
- Title: Safety and Pharmacodynamic Effects of
VERVE-101, an Investigational DNA Base Editing Medicine Designed to
Durably Inactivate the PCSK9 Gene and Lower LDL Cholesterol -
Interim Results of the Phase 1b heart-1 Trial
- Session: Future of Lipid Lowering Therapy –
Novel Mechanisms and Approaches
- Date and Time: Sunday, November 12, 2023,
between 3:30 – 3:40 p.m. EST
Verve also plans to host an investor event in conjunction with
the data presentation on November 12, 2023. Details for the event
will be provided at a future date, and, once available, the
presentation will be archived on the Verve website at
www.vervetx.com.
About Verve Therapeutics Verve
Therapeutics, Inc. (Nasdaq: VERV) is a clinical-stage genetic
medicines company pioneering a new approach to the care of
cardiovascular disease, potentially transforming treatment from
chronic management to single-course gene editing medicines. The
company’s initial three programs – VERVE-101, VERVE-102, and
VERVE-201 – target genes that have been extensively validated as
targets for lowering low-density lipoprotein cholesterol (LDL-C), a
root cause of cardiovascular disease, in order to durably reduce
blood LDL-C levels. VERVE-101 and VERVE-102 are designed to
permanently turn off the PCSK9 gene in the liver and are being
developed initially for heterozygous familial hypercholesterolemia
(HeFH) and ultimately to treat atherosclerotic cardiovascular
disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is
designed to permanently turn off the ANGPTL3 gene in the liver and
is initially being developed for homozygous familial
hypercholesterolemia (HoFH) and ultimately to treat patients with
refractory hypercholesterolemia. For more information, please visit
www.VerveTx.com.
Cautionary Note Regarding Forward Looking
StatementsThis press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995 that involve substantial risks and
uncertainties, including statements regarding the timing and
availability of clinical data from its ongoing heart-1 trial and
the therapeutic potential of the company’s programs. All
statements, other than statements of historical facts, contained in
this press release, including statements regarding the company’s
strategy, future operations, future financial position, prospects,
plans and objectives of management, are forward-looking statements.
The words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” “would” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in,
or implied by, such forward-looking statements. These risks and
uncertainties include, but are not limited to, risks associated
with the company’s limited operating history; the company’s ability
to timely submit and receive approvals of regulatory applications
for its product candidates; advance its product candidates in
clinical trials; initiate, enroll and complete its ongoing and
future clinical trials on the timeline expected or at all;
correctly estimate the potential patient population and/or market
for the company’s product candidates; replicate in clinical trials
positive results found in preclinical studies and/or earlier-stage
clinical trials of VERVE-101, VERVE-102, and VERVE-201; advance the
development of its product candidates under the timelines it
anticipates in current and future clinical trials; obtain, maintain
or protect intellectual property rights related to its product
candidates; manage expenses; and raise the substantial additional
capital needed to achieve its business objectives. For a discussion
of other risks and uncertainties, and other important factors, any
of which could cause the company’s actual results to differ from
those contained in the forward-looking statements, see the “Risk
Factors” section, as well as discussions of potential risks,
uncertainties and other important factors, in the company’s most
recent filings with the Securities and Exchange Commission and in
other filings that the company makes with the Securities and
Exchange Commission in the future. In addition, the forward-looking
statements included in this press release represent the company’s
views as of the date hereof and should not be relied upon as
representing the company’s views as of any date subsequent to the
date hereof. The company anticipates that subsequent events and
developments will cause the company’s views to change. However,
while the company may elect to update these forward-looking
statements at some point in the future, the company specifically
disclaims any obligation to do so.
Investor Contact:Jen RobinsonVerve
Therapeutics, Inc.jrobinson@vervetx.com
Media ContactAshlea
Kosikowski1ABashlea@1abmedia.com
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