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The firibastat (originally named QGC001) product, a BAPAI candidate-drug, 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.
The aim of the study is to assess the efficacy and the safety of firibastat compared to ramipril. The primary endpoint is the change from baseline in Left Ventricle Ejection Fraction (LVEF) assessed by Cardiac Magnetic Resonance (CMR) after a three-month treatment.
Phase III Pivotal REFRESH Study is part of firibastat’s Phase III clinical development and aims to assess long-term safety as well as the three-month efficacy after a single daily dose of firibastat 1000mg in treatment resistant hypertensive patients.
Under the terms of the agreement, Faran will receive the exclusive rights to market Firibastat for the treatment of difficult-to-treat / resistant hypertension in Greece.
Under the terms of the agreement, Xediton Pharmaceuticals will receive exclusive commercialization rights to firibastat for the treatment of difficult to treat/resistant hypertension in Canada.
Under the terms of the agreement, Qilu Pharmaceutical will receive the exclusive rights to market firibastat for the treatment of difficult-to-treat / resistant hypertension in China, including Hong Kong and Macau.
First patient in the Company’s FRESH study (Firibastat in treatment-RESistant Hypertension) in difficult-to-treat(1) or resistant(2) hypertension. The study is being conducted jointly with its partner in Latin America, the Biolab Sanus Pharmaceutical laboratory.