Quantum Genomics Announces Positive FDA Feedback on Phase III Program Design of Firibastat in Resistant Arterial Hypertension
PARIS and NEW YORK, Sept. 02, 2019 (GLOBE NEWSWIRE) -- Quantum Genomics (Euronext Growth - FR0011648971 - ALQGC), a biopharmaceutical company specializing in the development of a new drug class that directly targets the brain to treat resistant arterial hypertension and heart failure, today announced that it met a new milestone of its strategic plan by receiving favourable feedback from the U.S. Food and Drug Administration (FDA) regarding the Company’s Phase III development plan and trial design for firibastat in patients with resistant arterial hypertension.
In a previously completed Phase IIb study presented at the American Heart Association (AHA) Scientific Sessions in November 2018, firibastat reached its primary endpoint and significantly lowered blood pressure to clinically relevant levels. Following these positive results, Quantum Genomics met formally with the FDA to potentially advance firibastat into two U.S. Phase III studies, one to evaluate efficacy and another to evaluate safety.
“Currently, 150 million people around the globe struggle with difficult-to-control or treatment-resistant arterial hypertension, and often times related complications,” said Jean-Philippe Milon, Chief Executive Officer of Quantum Genomics. “The positive feedback from the FDA regarding our clinical development plan to advance firibastat into Phase III trials in the United States represents a key milestone in the execution of our strategic plan as presented in April 2018. As of today, we have diligently worked to meet these milestones that we have set forth and look forward to meeting the coming ones. The pivotal Phase III efficacy study of firibastat in difficult-to-treat or treatment-resistant arterial hypertension will thus start by the end of 2019 and its results will be available in the second half of 2021.”
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 is listed on the Euronext Growth exchange in Paris (FR0011648971- ALQGC) and trades on the OTCQX Best Market in the United States (symbol: QNNTF).
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Contact information
| Quantum Genomics | |
| Jean-Philippe Milon CEO +33 (0)1 85 34 77 70 | | Marc Karako CFO - Investor Relations +33 (0)1 85 34 77 70 | |
| So Bang (Europe) | |
| Nathalie Boumendil Financial Communications +33 (0)6 85 82 41 95 | | Samuel Beaupain Media Relations and Scientific Communications +33 (0)6 88 48 48 02 | |
| LifeSci (USA) | |
| Dan Ferry Financial Communications +1 (617) 535-7746 | | Michael Tattory Media Relations and Scientific Communications +1 (646) 751-4362 | |
