Quantum Genomics Initiates its Pivotal Phase III FRESH Trial in Difficult-to-Treat and Resistant Hypertension

PARIS and NEW YORK, Dec. 19, 2019 (GLOBE NEWSWIRE) -- Quantum Genomics (Euronext Growth - FR0011648971 - ALQGC, OTCQX - QNNTF), a biopharmaceutical company specializing in developing a new drug class that directly targets the brain to treat resistant hypertension and heart failure, today announced the initiation of its pivotal Phase III FRESH study (Firibastat in treatment-RESistant Hypertension) in difficult-to-treat¹ and resistant² hypertension. The trial is being conducted in partnership with Biolab Sanus Pharmaceuticals, as announced on December 9, 2019.

This efficacy study will enroll 500 subjects with difficult-to-treat or resistant hypertension who will be randomized to receive a blind treatment with firibastat (500 mg BID), or placebo, for three months on top of their current therapy, in approximately 70 hospitals worldwide. The primary endpoint is change from baseline in systolic automated office blood pressure.

The trial is being conducted in Europe (France, Germany, Poland, Spain and Czech Republic), Canada, USA and Latin America (Brazil & Mexico), with the support of the CROs (Contract Research Organisations) PRA Health sciences for Europe, Canada and the US and Azidus for Latin America.

Biolab Sanus Pharmaceuticals will be responsible for trial costs in Latin America, which will account for approximately 100 (20%) of the 500 patients enrolled in the study.

The final protocol has been completed, site selection is ongoing and regulatory (ethic committees and competent authorities) files are in preparation for each country. The first patient enrollment is expected in the first quarter of 2020 and top-line efficacy results are anticipated in the second half of 2021.

(1) Patients not controlled despite two antihypertensive classes, including a diuretic, at maximum tolerated doses.

(2) Patients not controlled despite at least three antihypertensive classes, including a diuretic, at maximum tolerated doses.

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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