First subjects treated in the first human trial for VarmX’s anticoagulant reversal agent, VMX-C001
The trial will assess the safety, tolerability, PK and PD of VMX-C001
Major Company Milestone Reached as VarmX Transforms into a Clinical-Stage Company
LEIDEN, Netherlands, December 15, 2021– (BUSINESS WIRE) – VarmX, a clinical-stage biotechnology company focused on developing innovative approaches for reversing anticoagulation, today announced the treatment of the first subjects in its first study in the man for the lead compound VMX-C001, and VarmX’s transition from a preclinical to a clinical business.
The two-part study is a randomized, double-blind, single-dose ascending trial in healthy subjects. It will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001 administered intravenously, both alone and in combination with certain direct oral anticoagulants (DOAs). It is expected that up to 88 participants will be registered.
In the United States and Europe combined, more than 10 million patients take long-term factor Xa (FXa) DOACs for the prevention of stroke and deep vein thrombosis. Each year, 2-3% of these patients experience spontaneous severe bleeding as a side effect of DOAC use, and others require emergency surgery, with a risk of associated bleeding.
The VMX-C001 is able to quickly and efficiently restore coagulation in the presence of FXa AOD. In so doing, the compound can facilitate the treatment of severe bleeding and enable patients to undergo emergency surgery without the risk of bleeding associated with unopposed DOACs. VMX-C001 is expected to offer a number of advantages over existing treatments, including universal efficacy against any FXa DOA, ease of dosing and administration, no increased thrombotic risk, and the ability to use heparin if necessary.
Gerard Short, Medical Director of VarmX, said: “In addition to bringing our potentially life-saving anticoagulant reversal agent closer to patients, the start of this first human trial marks a major milestone in the development of VarmX’s business. As the first of our products to enter the clinic, VMX -C001 spearheads our growth into a clinical business, a key aspect of our strategy. Our mission is to respond to the clear and urgent need for therapies to treat or prevent severe bleeding in patients taking DOACs. “
The clinical development of VMX-C001 will be funded in part by recently awarded funding of up to € 17.5 million from the European Innovation Council (EIC) accelerator.
For more information on the first human trial, please visit clinicaltrials.gov.
Notes to Editors
VarmX is a clinical stage pharmaceutical company founded in 2016 by Prof. Pieter Reitsma, a global expert in hemostasis and thrombosis, as a spin-off of Leiden University Medical Center (LUMC).
The main compound of VarmX, VMX-C001, is a modified recombinant human blood factor X based on the venom of the Australian brown snake, Pseudonaja textilis. The compound is under development for the treatment of spontaneous bleeding and the prevention of bleeding during surgery in patients taking direct oral factor Xa anticoagulants (FXa DOAC).
In July 2020, VarmX raised € 32 million in Series B financing, backed by a strong syndicate of investors including Ysios Capital, INKEF Capital, Lundbeckfonden Ventures, LSP, BioGeneration Ventures and the development fund Regional Economic InnovationQuarter. This was followed by the announcement in October 2021 of funding of up to € 17.5 million from the European Innovation Council (EIC) accelerator.
For more information, please visit the website: www.varmx.com.
See the source version on businesswire.com: https://www.businesswire.com/news/home/20211215005083/en/
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