Phase IIb clinical study assessing the efficacy and safety of firibastat compared to ramipril in patients with reduced ejection fraction following acute myocardial infarction (AMI)
Launch by the end of 2018 in Europe and in the US, expected results in mid-2020
Quantum Genomics (Euronext Growth: ALQGC, OTCQX: QNNTF), a biopharmaceutical company with the mission of developing new therapies for unmet medical needs in the field of cardiovascular diseases, announced today the design of its next phase II trial in heart failure with its first-in class drug-candidate firibastat (QGC001).
The aim of this study named QUORUM (QUantum Genomics QCG001 Or Ramipril after acUte Myocardial infarction to prevent left ventricular dysfunction) will be to assess the efficacy and the safety of firibastat compared to ramipril1, in subjects with reduced ejection fraction following acute myocardial infarction (AMI). Firibastat targets the brain renin-angiotensin system. Through a triple mechanism of action, firibastat makes it possible to produce a simultaneous effect on the arteries, heart and kidney, offering promising perspectives in the treatment of heart failure (HF).
QUORUM will be a multicenter, multinational, randomized, double-blind, active-controlled trial with 3 parallel groups. The study will enroll approximately 300 subjects, enrolled within 24h after AMI, treated with primary percutaneous coronary intervention (PCI) and with reduced left ventricular ejection fraction (LVEF). Study subjects will be randomized to receive either low dose of firibastat, standard dose of firibastat or ramipril for 3 months.
The primary endpoint will be the change from baseline in LVEF assessed by cardiac magnetic resonance (CMR) after a 3-month treatment. Other endpoints will include cardiac events, functional status, safety and change in HF biomarkers.
Bruno Besse, Chief Medical Officer of Quantum Genomics: “we have decided to launch a phase IIb to assess efficacy and safety of firibastat in post-MI patients, in order to be as close as possible to our preclinical models. Indeed, our latest data in post myocardial infarction mice and rats showed significant cardiac function improvement in animals treated by oral doses of firibastat, and the good safety profile of firibastat observed in HF patients during the phase IIa clinical study (QUID HF) makes us confident.
The study will be conducted in approximately 40 clinical centers in Europe and in the US. Quantum Genomics is targeting to start the study by the end of 2018 and expects the results around mid-2020.
Pr Gilles Montalescot (Paris, France) will be QUORUM's Principal Investigator and will chair an international Steering Committee composed of Pr John H. Alexander (Durham, USA), Pr Leonardo Bolognese (Florence, Italy), Pr Angel-Ramon Cequier (Barcelona, Spain) and Pr Harald Darius (Berlin, Germany).
Gilles Montalescot “Heart attack or AMI is one of the most common cause of cardiac hospitalization. The number of death from AMI in hospital has decreased but the number of patients developing HF, a common complication following an AMI, has increased. Data from registries and clinical trials show the unmet need for new therapeutic approaches to reduce HF-related morbidity and mortality in post-AMI patients. We are therefore very excited to see the development of a new therapeutic class in this indication. This study design is resolutely ambitious, and our objective is to make it a true proof of concept.”
Cardiovascular diseases are the highest cause of mortality in the world, causing 17,7 million deaths, representing 31% of total global mortality2. 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 risk3. 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 failure5.
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 drugs based on the Brain Aminopeptidase A Inhibition (BAPAI). The only company in the world exploring this innovative approach, which directly targets the brain, it relies on its 20 years of academic and clinical research in some of the largest French laboratories (The French National Institute of Health and Medical Research (INSERM), the Scientific Centre for National Research (CNRS), the Collège de France, and the Paris-Descartes University). 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 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
4 Tayal et al. Genome Medicine (2017) 9:20