Quantum Genomics Receives First Regulatory and Ethics Approvals to Initiate Phase IIb QUORUM Study of Firibastat in Heart Failure
PARIS and NEW YORK, April 17, 2019 (GLOBE NEWSWIRE) -- Quantum Genomics (Euronext Growth: ALQGC, OTCQX: QNNTF), a biopharmaceutical company specializing in the development of a new drug class that directly targets the brain to treat resistant hypertension and heart failure, today announced the first regulatory and ethics approvals for its Phase IIb QUORUM study of firibastat in heart failure.
The French National Agency for Medicines and Health Products Safety (ANSM) in France was the first Health Authority to approve the study which will be conducted in seven European countries (France, Germany, Hungary, Poland, Slovakia, Spain, UK) and in the US.
QUORUM (QUantum Genomics QCG001 Or Ramipril after acUte Myocardial infarction to prevent left ventricular dysfunction) is a multi-center, multinational, randomized, double-blind, active-controlled trial with three parallel groups (firibastat 100 mg BID, firibastat 250 mg BID and ramipril 5 mg BID). The study will enroll 294 subjects within 24 hours after Acute Myocardial Infarction (AMI), treated with primary Percutaneous Coronary Intervention (PCI). The aim of the study is to assess the efficacy and the safety of firibastat compared to ramipril1. The primary endpoint will be the change from baseline in Left Ventricle Ejection Fraction (LVEF) assessed by Cardiac Magnetic Resonance (CMR) after a three-month treatment. Other endpoints will include cardiac events, functional status, safety and change in HF biomarkers.
Bruno Besse, Chief Medical Officer of Quantum Genomics commented: “Approval by both regulatory authorities and ethics committees is a major milestone for QUORUM. It is the first trial in recent years to study a new therapeutic class instead of Angiotensin-Converting Enzyme (ACE)-inhibitors and not on top of ACE-inhibitors, demonstrating further support for Quantum Genomics’ efforts to deliver on firibastat’s potential as a well-tolerated alternative to the ACE-inhibitors for the treatment of heart failure.”
Prof. Gilles Montalescot (Paris, France) is QUORUM’s Principal Investigator and is chairing an international Steering Committee composed of Prof. John H. Alexander (Durham, USA), Prof. Leonardo Bolognese (Florence, Italy), Prof. Angel-Ramon Cequier (Barcelona, Spain) and Prof. Harald Darius (Berlin, Germany).
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Cardiovascular diseases are the highest cause of mortality in the world, causing 17,7 million deaths, representing 31% of total global mortality.2 In France alone, despite considerable therapeutic progress, cardiovascular diseases are the root cause of around 140,000 deaths per year; they are also one of the main causes of morbidity with 11 million patients treated for vascular risk.3 In total they represent 28 billion euros in annual expenditure.
- Heart failure, the largest cause of hospitalization in France among adults
40 million4 people suffer from heart failure worldwide and more than 1 million in France alone. The frequency of the disease has doubled in 10 years. Heart failure often results in death and its prognosis is always especially dark.
- Restrictive and not always effective treatments
In heart failure, different families of treatments can be combined depending on the patient, however morbidity and mortality are not lower: half of the patients die in the 3 to 5 years following onset of the symptoms of heart failure.5
The new therapeutic group developed by Quantum Genomics is therefore promising for millions of patients worldwide.
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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1 Ramipril is an Angiotensin-Converting-Enzyme (ACE) inhibitor, reference therapy in heart failure, including patients developing heart failure after acute myocardial infarction
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4 Tayal et al. Genome Medicine (2017) 9:20
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