Paris & New York, June 28, 2017
Quantum Genomics (Euronext Growth - FR0011648971 - ALQGC), a biopharmaceutical company with the mission of developing new therapies for unmet medical needs in the field of cardiovascular diseases, announces the design of its next Phase II trial in arterial hypertension (HTN), NEW-HOPE, with its drug candidate QGC001, on 250 high cardiovascular risk patients.
At the end of this trial – the results of which are expected in the first half of 2019 – a Phase III clinical trial could then be initiated with QGC001.
HTN, a major public health problem, affects more than one in three adults, and more than one in two adults over the age of 50. This cardiovascular disease is present worldwide. More than half of hypertensive patients, including those in developed countries, are not treated, and only 40% of those who are treated are properly controlled.
Lionel Ségard, Chairman & CEO of Quantum Genomics, says:
"In the absence of satisfactory treatments to date and after guidance from the FDA (Food and Drug Administration), we have decided to launch, this fall, a new study called NEW-HOPE, for "Novel Evaluation With QGC001 in Hypertensive Overweight Patients of Multiple Ethnic Origins", which will mainly target a population of hypertensive patients with a particular profile known as "Low Renin High Vasopressin" (LRHV) and that often has resistant HTN.
QGC001 : Phase IIa shows greater blood pressure drop in the most hypertensive patients
QGC001 is the first molecule of a new class of antihypertensive agents called BAPAIs (Brain Aminopeptidase A Inhibitors). The Phase IIa clinical trial, the results of which were presented at the ESH this month, validated the proof of concept previously obtained in animals, confirming that brain aminopeptidase A inhibition does lead to an antihypertensive effect in humans.
In particular, the drug candidate QGC001 showed in this study that it led to a decrease in blood pressure in non-selected hypertensive patients. The higher was the baseline blood pressure, the greater was this antihypertensive effect. Plasma concentrations of the main hormones involved in blood pressure regulation (including renin and aldosterone) did not vary during treatment, thus confirming that QGC001 mode of action is totally original and different from that of existing products.
The study also confirmed the good tolerance and safety of QGC001, particularly the absence of adverse effects on renal function and on potassium and sodium plasma levels.
After these positive results, Quantum Genomics intends to continue QGC001 development on its target population, where its effect has the most likelihood of being decisive.
The NEW-HOPE trial will be conducted in 25 centers in the United States, on 250 high-risk hypertensive patients (overweight and with higher baseline blood pressure than in the previous trial), including a significant proportion of patients being from minorities.
Prof. Keith C. Ferdinand, member of the Quantum Genomics Clinical Ethics Committee and arterial hypertension specialist, says:
"Studies have shown that African-Americans, Hispanic and Asian-American populations more frequently have uncontrolled hypertension, often complicated or even resistant. In other words, these are patients with poorly controlled hypertension or for whom treatment has failed. Some of the frequently used treatment (such as ACE- inhibitors) are ineffective in these patients, especially in African Americans and other more effective ones such as diuretics (hydrochlorothiazide or chlorthalidone) may have undesirable side-effects, in particular a tendency to reduce blood potassium levels (hypokalemia) or sodium levels (hyponatremia). It is therefore necessary to develop a new therapeutic care approach for these patients."
It is important to note that older patients, regardless of race/ethnicity, may reflect this patient profile, which can also be found in elderly Caucasian patients.
After two weeks of halting all hypertensive treatment, the patients will receive QCC001 treatment for eight weeks. The initial QGC01 dose, 250 mg twice a day, will be increased if necessary to 500 mg twice a day. A diuretic treatment (25 mg hydrochlorothiazide) may be added, as this is often the treatment protocol for this type of patients.
The primary efficacy criterion will be a drop in office blood pressure after eight weeks. 24hr-Ambulatory blood pressure measurements (ABPM) will also be recorded after eight weeks. Response-rate will be measured, as well as predictive factors for response. Safety data will also be monitored.
QGC001, Quantum Genomics' lead Brain Aminopeptidase A Inhibitor (BAPAI) candidate, is a first-in-class standalone treatment for hypertension. Functionally, QGC001 is a prodrug of EC33, a selective and specific inhibitor of Aminopeptidase A that prevents the production of Angiotensin III in the brain.
Due to its unique action mechanism, QGC001 is an improved therapeutic approach which interferes with mechanisms involved in the genesis and control of high blood pressure in hypertensive patients, especially in those who exhibit a particular hormonal profile characterized by a low renin and a high vasopressin concentration (Low Renin High Vasopressin (LRHV) profile).
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ABOUT QUANTUM GENOMICS
Quantum Genomics is a biopharmaceutical company with the mission of developing new therapies for unmet medical needs in the field of cardiovascular diseases, especially hypertension and heart failure.
The Company is developing a new therapeutic approach based on BAPAI (Brain Aminopeptidase A Inhibition). This is the result of more than 20 years of academic research in the laboratories of the Collège de France, INSERM, CNRS and the University of Paris Descartes.
Quantum Genomics is listed on the Euronext Growth market in Paris (isin code FR0011648971, Ticker ALQGC).
The Company has offices in Paris, France, and New York, NY, USA. For more information, please visit www.quantum-genomics.com.