These data open the way to BAPAIs for the treatment of cardiovascular diseases
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Launch of a phase II clinical study most important in the United States
Quantum Genomics (Alternext — FR0011648971 — ALQGC), a biopharmaceutical company specializing in the development of new therapies for unmet medical needs in the field of cardiovascular diseases, announced today that its drug candidate QCC001 has shown effectiveness in patients with arterial hypertension mild to moderate, according to the results of the pilot study phase IIa.
The results of this study were presented on June 18, 2017 by the principal investigator of the study, Professor Michel Azizi, Director of the clinical investigation Centre and Head of the Department of Arterial Hypertension of the european Hospital Georges Pompidou (Paris), at the congress of the European Society of Hypertension (ESH) in Milan.
QGC001 is the first molecule of a new class of antihypertensive agents called BAPAIs (Brain Aminopeptidase A inhibitors), and inhibitors of the aminopeptidase Has the brain. It is a prodrug that releases in the brain the EC33, a selective inhibitor and a specific aminopeptidase A, and thus prevent the production of angiotensin III in the brain.
Lionel Ségard, Chairman and ceo of Quantum Genomics, says :
We are very pleased to present these positive results, perfectly in line with our expectations. They are an important milestone in our strategy and show that inhibitors of aminopeptidase A cerebral have an antihypertensive effect, and, as such, they constitute a new class of drugs promising which opens the way to new treatments of high blood pressure. They validate the result of our clinical development, in particular the launch of a phase II study in more wide, on hypertensive patients at higher cardiovascular risk, which will begin as early as the fall of the United States .
The experimental plan used for this phase IIa study was a multicenter, crossover, randomized, double-blind, and titration, forced two periods of four weeks each. The main objective was to evaluate in 34 patients with hypertension grade I or II (systolic pressure : > 140 and ≤ 179 mmHg ; diastolic blood pressure : > 90 and ≤ 109 mmHg), the effect on the blood pressure of the QGC001 administered orally at the dose of 250 mg 2 times a day for 1 week and then at the dose of 500 mg 2 times per day for 3 weeks compared to a placebo treatment. This study also aimed to assess the safety and tolerance of the QGC001 and its effects on the plasma levels of hormones involved in the cardiovascular regulation.
The multivariate analysis of the data revealed an effect of the blood pressure to baseline (p=0.01) and treatment by QGC001 (p=0.06) on the decrease of systolic blood pressure ambulatory.
The study has highlighted, despite the small size of the sample, that the QGC001 caused a decrease of the systolic blood pressure in ambulatory (primary endpoint assessment) of 2.7 mmHg (p=0.16) and of the systolic blood pressure in the medical consultation of 4.7 mmHg (p=0.15), in comparison with the placebo group in which no decrease of the blood pressure was not observed.
A larger decrease in patients with hypertension
Bruno Besse, Medical Director of Quantum Genomics, says :
«In a remarkable way, the study has also shown that the antihypertensive effect of QGC001 is all the more important that the blood pressure of patients is high. This seems to validate the hypothesis according to which QGC001 could be particularly effective in patients with hypertension complicated, which will be the subject of a phase II study in more wide that will be launched as early as autumn in the United States. »
The objective of this study was to demonstrate the proof-of-concept in humans, as had previously been demonstrated in the animal, and to define the profile of future clinical studies.
The findings of the study are perfectly consistent with the experimental results in animals. No effect was found in normotensive rats but decreased the blood pressure had been observed in spontaneously hypertensive rats (SHR and DOCA-salt rats), in which the aminopeptidase Has the brain is hyperactive, in comparison with normotensive animals : in the same way in phase I in humans, QGC001 did not imply any decrease of the blood pressure in healthy volunteers and, therefore, normotensive
The clinical trial has also highlighted the absence of change in plasma concentrations of hormones such as the renin active, the aldosterone, the cortisol, the hormone adrénocorticotropique, the copeptine and apelin, in the group QGC001 or in the placebo group, thus confirming that the mechanism of action of QGC001 does not pass through the renin or aldosterone.
The good tolerance on the renal function, and electrolytes in blood such as sodium and potassium, is particularly important in the perspective of a potential use of QGC001 in the treatment of heart failure, indication for which Quantum Genomics has already launched a phase II clinical study of pan-european, which is currently in progress.
In general, the safety profile of QGC001 is in accordance with what had been observed during the clinical trials of phase I.
As a result of the recommendations of the FDA (Food and Drug Administration), Quantum Genomics is preparing a phase II study which will be launched in the fall of 2017 in the United States. This study called NEW-HOPE, will be about 250 hypertensive patients at higher cardiovascular risk.
More details on this study will be provided during the KOL (opinion leaders) & Investor Day, which will be held on June 27 in New York (United States).
Quantum Genomics will host a conference call (in English) today at 18: 00, during which it will present these results to QGC001 to the financial community.
Event : conference call and webcast on results from phase IIa
Date : June 19, 2017
Time : 18: 00
Link live streaming : Click here
French number : +08009-02349
Number us and canada : +1-844-740-1264
English number : +08000-315370
Italian number : +08007-94054
Conference number: 667-273-987
QGC001 is the first molecule of a new class of antihypertensive agents called BAPAIs (Brain Aminopeptidase A inhibitors — Inhibitors of the Aminopeptidase Has at the cerebral level). It is a prodrug that releases in the brain the EC33, a selective inhibitor and a specific Aminopeptidase A, and thus prevent the production of Angiotensin III in the brain.
Because of its unique mechanism of action, QGC001 is an alternative therapeutic approach which may interfere with the mechanisms involved in the genesis and maintenance of blood pressure in hypertensive patients, especially those with a hormonal profile particular, characterized by a concentration of low-renin and vasopressin (higher profile Low Renin High Vasopressin (LRHV)).
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