French-based bio-pharmaceutical company Quantum Genomics has reported positive top-line data from its Phase IIa trial of QGC001 to treat hypertension (high blood pressure).
Originally known as RB150, QGC001 is the first BAPAI candidate-drug selected by Quantum Genomics.
It is a pro-drug delivering the EC33 product, a selective and specific inhibitor of Aminopeptidase A, thereby blocking the production of Angiontensin III in the brain.
QGC001 poses as an alternative therapeutic approach, which can modulate the mechanisms involved in the genesis and control of blood pressure in hypertensive patients, especially those with a particular hormonal profile, characterised by a low renin concentration and high vasopressin concentration or low renin high vasopressin (LRHV) profile.
The Phase IIa, double-blind crossover study involved 34 patients with moderate Grade I to II hypertension who were randomised to be administered with QGC001 and placebo based on an alternation of two 28-day sequences, separated by a 14-day no treatment period.
Data suggested the study met its primary endpoints, specifically a reduced daytime systolic blood pressure measured as ambulatory pressure in hypertensive patients who were treated with QGC001 compared with placebo.
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The positive result was further validated by in-depth multivariate analysis.
Quantum Genomics chief medical officer Dr Olivier Madonna said: "It is very encouraging for the lead product candidate in our new class of anti-hypertensive therapeutics to obtain these results in its first Phase II clinical trial.
“This study evaluated general hypertensive patients reflective of a major patient population in the EU and US and reinforces our QGC001 development strategy and allows us now to initiate a new Phase II trial in hypertensive patients requiring new treatment options to effectively control their high blood pressure.”
The company is also exploring options of conducting further clinical trials of QGC001 in Europe and Asia.