The FIRIBASTAT (originally named QGC001) product is the first BAPAI candidate-drug selected by Quantum Genomics. The FIRIBASTAT product is a prodrug that delivers in the brain the EC33 product, a selective and specific inhibitor of Aminopeptidase A, thus preventing the production of Angiontensin III in the brain.
Due to its unique action mechanism, FIRIBASTAT represents an alternative therapeutic approach which can interfere with the mechanisms involved in the genesis and control of blood pressure in hypertensive patients, especially those with a particular hormonal profile, characterized by a low renin concentration and a high vasopressin concentration (Low Renin High Vasopressin (LRHV) profile).
QGC001 and its therapeutic use are strongly protected by several families of patents ensuring an industrial protection until 2033 without taking into consideration the potential additional protection certificates.
Several preclinical studies and two clinical studies have been conducted already using FIRIBASTAT to assess its pharmacokinetic, pharmacodynamic, safety and tolerance parameters in animals and humans. In 2014, Quantum Genomics intends to pursue the clinical development of FIRIBASTAT by initiating a phase IIa study to evaluate its effectiveness in hypertensive patients.
The Phase IIa clinical trials for high blood pressure (FIRIBASTAT program) were completed in April 2016 and company reveals positive results in June 2017 at the ESH congress.
The resulting data showed positive signals over several parameters of the study, particularly on the main indicator (primary endpoint), the drop in daytime systolic blood pressure measured as ambulatory pressure in hypertensive patients.
Following FDA (Food and Drug Administration) guidance, Quantum Genomics is preparing a larger Phase II study to be launched in autumn 2017 in the United States. Called NEW-HOPE, this study will cover 250 hypertensive patients with higher cardiovascular risks.