Drugs / VERVE-101
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | homozygous familial hypercholesterolemia | 2023-03-02 | “its Investigational New Drug (IND) application for VERVE-101 was placed on hold and subsequently received a clinical hold letter from the FDA” vervetx.com ↗ |
| Clinical hold | US (FDA) | — | homozygous familial hypercholesterolemia | 2022-11-04 | “Verve submitted its IND application for VERVE-101 to the FDA in October and received notification of a hold from the FDA on Friday, November 4, 2022.” vervetx.com ↗ “the U.S. Food and Drug Administration (FDA) has placed a hold on its IND application to conduct a clinical trial evaluating VERVE-101” vervetx.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05398029 | Jul 2022 → Feb 2025 | atherosclerotic cardiovascular disease, familial hypercholesterolemia | Verve Therapeutics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2024-04-02 | Verve Therapeutics, Inc. | Results Verve Therapeutics Announces Updates on its PCSK9 Program vervetx.com ↗
Heart-1 clinical trial demonstrated LDL-C reduction of up to 73% at 0.45 mg/kg of VERVE-101 |
| 2023-11-12 | Verve Therapeutics, Inc. | Results Verve Therapeutics Announces Interim Data for VERVE-101 Demonstrating First Human Proof-of-Concept for In Vivo Base Editing with Dose-Dependent Reductions in LDL-C and Blood PCSK9 Protein in Patients with Heterozygous Familial Hypercholesterolemia vervetx.com ↗
Treatment with VERVE-101 led to dose-dependent reductions of disease-causing low-density lipoprotein cholesterol (LDL-C) in people living with heterozygous familial hypercholesterolemia (HeFH), a life-threatening inherited disease characterized by lifelong elevations in blood LDL-C and accelerated atherosclerotic cardiovascular disease (ASCVD). |
| 2023-11-07 | Verve Therapeutics, Inc. | Regulatory Verve Therapeutics Highlights Recent Company Progress and Reports Third Quarter 2023 Financial Results vervetx.com ↗
We have obtained clearance of our first IND application from the FDA, which now enables us to add U.S. sites to the heart-1 trial and begins the regulatory path in the U.S. for VERVE-101. |
| 2023-10-23 | Verve Therapeutics, Inc. | Regulatory Verve Therapeutics Announces Clearance of Investigational New Drug Application by the U.S. FDA for VERVE-101 in Patients with Heterozygous Familial Hypercholesterolemia vervetx.com ↗
Verve Therapeutics Announces Clearance of Investigational New Drug Application by the U.S. FDA for VERVE-101 in Patients with Heterozygous Familial Hypercholesterolemia |
| 2023-02-14 | Verve Therapeutics, Inc. | Regulatory Verve Therapeutics Announces VERVE-101 Awarded Innovation Passport by the UK MHRA for the Treatment of Heterozygous Familial Hypercholesterolemia vervetx.com ↗
today announced that VERVE-101 has been awarded the Innovation Passport for the treatment of heterozygous familial hypercholesterolemia (HeFH) under the Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare products Regulatory Agency (MHRA) |
| 2022-11-07 | Verve Therapeutics, Inc. | Regulatory Verve Therapeutics Provides Regulatory Update on VERVE-101 Investigational New Drug Application and Reports Third Quarter 2022 Financial Results vervetx.com ↗ |
| 2022-10-31 | Verve Therapeutics, Inc. | Results Verve Therapeutics Announces Publication of VERVE-101 Preclinical Data in Circulation and Presentations at the American Heart Association Annual Meeting vervetx.com ↗
The animals in the 0.75 mg/kg arm were evaluated 365 days post-treatment and demonstrated a mean reduction in blood PCSK9 protein of 67% and LDL-C reduction of 49% from baseline. |
| 2022-09-21 | Verve Therapeutics, Inc. | Regulatory Verve Therapeutics Announces Clearance of Clinical Trial Authorisation Application by the United Kingdom Medicines and Healthcare Products Regulatory Agency for VERVE-101 in Patients with Heterozygous Familial Hypercholesterolemia vervetx.com ↗
Verve Therapeutics, Inc., a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced the clearance of its Clinical Trial Authorisation (CTA) application by the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) for VERVE-101 as a potential treatment for patients with heterozygous familial hypercholesterolemia (HeFH). |
| 2022-05-10 | Verve Therapeutics, Inc. | Regulatory Verve Therapeutics Announces Clearance of First VERVE-101 Clinical Trial Application and Outlines Global Clinical Development Strategy; Reports First Quarter 2022 Financial Results vervetx.com ↗
Verve has received clearance of its first clinical trial application (CTA) for VERVE-101 in New Zealand and plans to initiate a first-in-human Phase 1 clinical trial in patients with HeFH in mid-2022. |
| 2022-05-09 | Verve Therapeutics, Inc. | Results Verve Therapeutics Reports Additional VERVE-101 and GalNAc-Lipid Nanoparticle Delivery Data in Non-Human Primates at TIDES USA 2022 vervetx.com ↗
Updated data with the clinical formulation of VERVE-101 demonstrated potent and durable editing of the PCSK9 gene and reductions of LDL-C in non-human primates (NHPs), with follow up now out to one year. |
| 2022-04-26 | Verve Therapeutics, Inc. | Results Verve Therapeutics Presents Comprehensive Analyses of Off-target Editing Risk for VERVE-101 at Precision Genome Engineering Keystone Symposia vervetx.com ↗ |
| 2022-01-10 | Verve Therapeutics, Inc. | Results Verve Therapeutics Announces 2022 Anticipated Milestones and Preclinical Data on Potential Additional Dosing Regimens for its Novel Base Editing Programs vervetx.com ↗
Preclinical Data in Non-Human Primates Demonstrate Potential to Re-Dose or Sequentially Dose Base Editing Programs |
| 2021-09-23 | Verve Therapeutics, Inc. | Results Verve Therapeutics Reports New Preclinical Data with VERVE-101 Demonstrating Robust, Durable and Precise Editing of the PCSK9 Gene for the Treatment of Cardiovascular Disease vervetx.com ↗
Findings from that study as well as additional studies in rodents demonstrated potent and durable lowering of blood PCSK9 protein and low-density lipoprotein cholesterol (LDL-C), with no evidence of adverse events or significant off-target editing. |
| 2021-05-19 | Verve Therapeutics, Inc. | Results Verve Therapeutics Announces Nature Publication Highlighting its Use of Base Editing to Potently and Durably Lower Blood PCSK9 and LDL-C in Non-Human Primates vervetx.com ↗
In this study, Verve observed potent and durable lowering of both blood PCSK9 protein and low-density lipoprotein cholesterol (LDL-C) levels of approximately 90% and 60%, respectively, following administration of a single gene editing treatment. |
| 2021-05-11 | Verve Therapeutics, Inc. | Results Verve Therapeutics to Present Preclinical Data from Gene Editing Programs for the Treatment of Atherosclerotic Cardiovascular Disease at ASGCT vervetx.com ↗
We’re pleased to present these preclinical data at ASGCT highlighting the progress made across our lead programs targeting PCSK9 and ANGPTL3. |
| 2021-01-21 | Verve Therapeutics, Inc. | Results Verve Therapeutics Announces Data Demonstrating Durable LDL Cholesterol Lowering After a One-Time Gene Editing Treatment in Non-Human Primates vervetx.com ↗
Verve Therapeutics, a biotech company pioneering gene editing medicines to treat cardiovascular disease, today announced new data demonstrating both durable and consistent lowering of blood low-density lipoprotein cholesterol (LDL-C) levels at six months after a single gene editing treatment in non-human primates. |
All press releases naming this drug 18 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VERVE-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05398029 ↗ |
| Action | Inhibit | “designed to disrupt the expression of the PCSK9 gene in the liver and lower circulating PCSK9 and LDL-C” NCT05398029 ↗ |
| Route | Intravenous | “Intravenous (IV) infusion.” NCT05398029 ↗ |
| Target | PCSK9 | “disrupt the expression of the PCSK9 gene” NCT05398029 ↗ |