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Release Details

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

Sep 26, 2023

Company to hold investor event in conjunction with data presentation on November 12, 2023

BOSTON, Sept. 26, 2023 (GLOBE NEWSWIRE) -- 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 Statements
This 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 Robinson
Verve Therapeutics, Inc.

Media Contact
Ashlea Kosikowski