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, announces today the completion of patient recruitment in its Phase IIb study, titled NEW-HOPE, evaluating its first-in-class drug firibastat as a treatment for hypertension among a high risk diverse population in the US, more than six months ahead of time.
NEW-HOPE is a phase IIb clinical study designed to evaluate the efficacy and safety of firibastat in the treatment of high blood pressure in hypertensive patients with high cardiovascular risk and from multiple ethnic origins. After a 2-week wash-out period, subjects received firibastat for 8 weeks (250 mg twice-a-day orally for 2 weeks, then 500 mg twice-a-day; hydrochlorothiazide 25 mg once daily could be added after 1 month if systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg). The primary endpoint is change from baseline in clinic systolic blood pressure (as measured by the SPRINT method). Secondary endpoints include changes in diastolic blood pressure, ambulatory blood pressure measurements and lab tests.
256 hypertensive subjects with high cardiovascular risk (mean baseline office systolic blood pressure: 154± 7 mmHg; diastolic blood pressure: 91±8 mmHg), overweight or obese (mean Body Mass Index 33±5 kg/m²), of whom 54% are from minorities (African-Americans or Hispanics) were recruited throughout the US within 10 months.
Professor Keith C. Ferdinand, NEW-HOPE Principal Investigator, said: “Having recruited 256 hypertensive high-risk diverse subjects, with more than 50% coming from minorities, in a so short period of time is a major achievement. There are so few studies that reflect this type of minority enrollment. The fact that we were able to recruit so quickly is a testament of both the strong commitment of the investigators and the high expectations of the subjects enrolled, who are for many of them likely to be less blood pressure responsive to some existing therapies such as ACE-I or ARBs.
Doctor Bruno Besse, Quantum Genomics Chief Medical Officer, added: “We do believe firibastat may be an alternative treatment in high-risk hypertensive population. Obviously, if the NEW-HOPE results meet the primary endpoint, they will represent a major milestone in the clinical development of firibastat and may support the design of a future phase III trial in resistant hypertension”
Arterial hypertension (HTN) is a global and major public health concern. It affects one third of the worldwide population and its prevalence increases with age. HTN is one of the leading risk factors for coronary heart disease, heart failure, stroke and renal insufficiency. Complications of HTN account for 10 million deaths worldwide each year.
Despite the availability of many antihypertensive drugs, HTN and its concomitant risk factors are still not successfully controlled in more than 50% of hypertensive patients. In some populations such African-Americans (AA), HTN occurs earlier; it is more severe and less controlled, and it has a higher morbidity and mortality than in U.S. Caucasians. AA are also less responsive to monotherapy with angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptors blockers. Obesity, higher salt-sensitivity and low plasma renin activity are among possible reasons for this less robust blood pressure response to initial therapy with renin angiotensin system modulation, especially in AA.
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 and relies on 20 years of academic research from the Paris-Descartes University and the laboratory managed by Dr. Catherine Llorens-Cortès 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 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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