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Quantum Genomics, the creators of Firibastat, a first-in-class brain aminopeptidase inhibitor (BAPAI) that could potentially treat treatment-resistant hypertension by acting in the brain to interfere with the renin-angiotensin system announced that it met a new milestone of its strategic plan by receiving favorable feedback from the U.S. Food and Drug Administration (FDA) regarding the Company’s Phase III development plan and trial design for firibastat.It is estimated that there are around 150 million people worldwide that are affected by treatment-resistant hypertension, resulting in almost 10 million deaths per year from complications due to high blood pressure. With such a high number of people dealing with this chronic condition (around 1.1 billion people). For those with treatment resistant hypertension, they can be more susceptible to complications associated with hypertension such as heart failure, coronary artery disease, stroke, kidney disease and peripheral artery disease.
Firibastat works by crossing the blood-brain barrier and modulating the brain renin-angiotensin system (RAS). RAS is a hormone system that controls blood pressure in part by modulating dilation and constriction of the blood vessels throughout the body, there is a RAS system in the brain, and at the peripheral level (kidney, heart…). By modulating the brain RAS, Firibastat decreases vasopressin release, decreases sympathetic nerve activity and improves baroreflex. These effects lead to a vasodilatation and an increased diuresis, thereby decreasing blood pressure.
The Company’s efficacy study, QGC001/3QG1, will be a three-month double-blind, placebo-controlled study assessing the efficacy of firibastat to reduce hypertension in patients with difficult-to-treat or resistant hypertension. QGC001/3QG1 is expected to enroll 500 hypertensive patients with systolic automated office blood pressure (AOBP) above 140 mmHg despite being treated with two (difficult- to-treat) or three anti-antihypertensive classes including a diuretic (resistant). Patients will receive firibastat or placebo on top of their current treatment. The primary endpoint will be change from baseline in systolic AOBP.
The Company’s safety study, QGC001/3QG2, will be an open label study assessing the long-term safety of firibastat. QGC001/3QG2 is expected to enroll 750 difficult-to-treat or resistant hypertensive patients with systolic AOBP above 140 mmHg. 650 patients will receive firibastat for six months, and 100 patients will receive firibastat for one year.
About Quantum Genomics
Quantum Genomics is a biopharmaceutical company specializing in the development of a new class of cardiovascular medications based on brain aminopeptidase A inhibition (BAPAI). Quantum Genomics is the only company in the world exploring this innovative approach that directly targets the brain. The company relies on 20 years of academic research from the Paris-Descartes University and the laboratory directed by Dr. Catherine Llorens-Cortes at the Collège de France (French National Institute of Health and Medical Research (INSERM)/ the Scientific Centre for National Research (CNRS)). The goal of Quantum Genomics is to develop innovative treatments for complicated, or even resistant, cases of hypertension (around 30% of patients have poor control of their condition or receive ineffective treatment) and for heart failure (one in two patients diagnosed with severe heart failure dies within five years).
Based in Paris and New York, Quantum Genomics trades on the OTCQX in the United States (symbol: QNNTF) and Euronext Paris (symbol: ALQGC). For more information, please visit http://www.quantum-genomics.com/ , or follow us on Twitter and LinkedIn.
Contact Info:
Name: Jean-Philippe MILON (CEO)
Email: Send Email
Organization: Quantum Genomics
Address: 33 avenue du Maine, Paris, FR
Phone: +33 (0)1 85 34 77 70
Website: http://www.quantum-genomics.com/www/en/
Release ID: 88928939
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