Paris & New York, 15 November 2017
· A study to improve targeting is being carried out in the United States
· NEW-HOPE: Galien MedStartUp Award-Winning Phase II Clinical Trial
Quantum Genomics (Euronext Growth – FR0011648971 – ALQGC), a biopharmaceutical company specialising in the development of a new drug class that directly targets the brain to treat hypertension and heart failure, announced today the recruitment of the first patients in the United States to participate in the NEW-HOPE study, designed to evaluate the efficacy of the drug candidate QGC001 in the treatment of high blood pressure.
NEW-HOPE (Novel Evaluation With QGC001 in Hypertensive Overweight Patients of Multiple Ethnic Origins) is a phase II study being conducted across 25 hospitals in the United States. It will recruit 250 hypertensive patients who are either overweight or obese. The study was launched in late September in the wake of a clinical investigators' meeting held in Chicago and attended by the steering committee, chaired by Professor Keith C. Ferdinand, an American specialist in hypertension. Since then, the majority of study centres (17 out of 25) have already initiated the patient selection phase and the first 14 patients have now begun treatment. Study results are expected in the first half of 2019.
"The recruitment of the first patients marks the effective start of our NEW-HOPE study, and physician anticipation is palpable with respect to testing this new drug. The goal of NEW-HOPE is to demonstrate the efficacy of QGC001 as a new therapeutic option in the treatment of high blood pressure, especially in large segments of the population suffering from complicated, even resistant, hypertension whose condition is poorly controlled by current treatments or in whom treatment has failed", said Lionel Ségard, ceo of Quantum Genomics.
After two weeks of discontinuing all antihypertensive medication, patients will receive QGC001 treatment for an eight-week period. The initial dose of QGC001 (250 mg twice a day) may be increased to 500 mg twice a day, if necessary. Diuretic therapy (hydrochlorothiazide 25 mg) may also be initiated, as is often the case in these types of patients.
The primary efficacy endpoint is a lower blood pressure reading after the eight-week period, when patients return to the medical centre for testing. Ambulatory blood pressure monitoring (ABPM) will also be carried out after eight weeks. Responder rates, as well as predictive factors for treatment response, will be measured. Tolerance data will also be monitored.
An innovative study to improve targeting is being carried out in the United States
Quantum Genomics received the 2017 Galien MedStartUp Award for the “Best Innovative Clinical Study Design” in New York on 26 October. The innovative nature of the NEW-HOPE study is primarily due to its high inclusion (up to 50%) of American patients from ethnic minorities (those of African-American, Hispanic, and Asian descent).
Indeed, a particular hormonal profile known as LRHV (Low Renin, High Vasopressin), characterised by a reduced concentration of renin and increased vasopressin, is overrepresented in these patients. LRHV patients are likely to have a poor response to current treatments such as angiotensin I-converting enzyme inhibitors and angiotensin II receptor blockers.
"Several studies have shown that individuals of African-American, Hispanic, and Asian descent are more prone to complicated, as well as resistant, hypertension. These are patients whose condition is insufficiently controlled or in whom treatment has failed altogether. Hence the need to develop a new therapeutic approach to treat these patients”, states Dr Bruno Besse, Medical Director of Quantum Genomics.
These American ethnic minorities therefore constitute the best population segments on which to evaluate the effectiveness of QGC001 with respect to hypertensivity, as the LRHV profile generally affects approximately 30% of the adult population worldwide.
Hypertension is an irreversible cardiovascular disease. It constitutes a major public health issue. It affects more than one in three adults worldwide and more than one in two adults over 50 years of age. Worldwide, it is responsible for 9.4 million deaths each year, due to associated complications (coronary diseases, heart failure, kidney failure, stroke, etc.).
More than half of hypertensive patients, including those in developed countries, go untreated and approximately 30% of the treated population is poorly controlled or fails to respond to treatment.
“While we believe that QGC001 may represent an alternative therapeutic approach for the entire population of hypertensive patients worldwide, it is clear that we must prioritise those segments of the population who are suffering from an unmet medical need”, concluded the CEO of Quantum Genomics.
About Quantum Genomics
Quantum Genomics is a biopharmaceutical company specialising in the development of a new class of cardiovascular drugs 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 its 20-plus years of basic and clinical research at some of the largest French laboratories (The French National Institute of Health and Medical Research (INSERM), the French National Centre for Scientific Research (CNRS), the Collège de France, and Paris-Descartes University). The goal of Quantum Genomics is to develop innovative treatments for complicated, or even resistant, cases of arterial hypertension (around 30% of patients have poor control of their condition or receive ineffective treatment) and for congestive heart failure (one in two patients diagnosed with congestive heart failure dies within five years).
Based in Paris and New York, the company is listed on the Euronext Growth exchange in Paris (FR0011648971 - ALQGC) and trades on the OTCQX market in the United States (symbol: QNNTF). For more information, visit www.quantum-genomics.com. Follow us on Twitter and Linkedin.
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