Quantum Genomics Initiates its Trial in Difficult-to-Treat and Resistant Hypertension

Quantum Genomics announced the initiation of its pivotal Phase III FRESH study (Firibastat in treatment-RESistant Hypertension) in difficult-to-treat1 and resistant2 hypertension. The trial is being conducted in partnership with Biolab Sanus Pharmaceuticals, as announced on December 9, 2019.

This efficacy study will enroll 500 subjects with difficult-to-treat or resistant hypertension who will be randomized to receive a blind treatment with firibastat (500 mg BID), or placebo, for three months on top of their current therapy, in approximately 70 hospitals worldwide. The primary endpoint is change from baseline in systolic automated office blood pressure.

The trial is being conducted in Europe (France, Germany, Poland, Spain and Czech Republic), Canada, USA and Latin America (Brazil & Mexico), with the support of the CROs (Contract Research Organisations) PRA Health sciences for Europe, Canada and the US and Azidus for Latin America.

Biolab Sanus Pharmaceuticals will be responsible for trial costs in Latin America, which will account for approximately 100 (20%) of the 500 patients enrolled in the study.

The final protocol has been completed, site selection is ongoing and regulatory (ethic committees and competent authorities) files are in preparation for each country. The first patient enrollment is expected in the first quarter of 2020 and top-line efficacy results are anticipated in the second half of 2021.

Editor's Note:

En-CPhI.CN is a vertical B2B online trade platform serving the pharmaceutical industry,

for any copyright disputes involved in the reproduced articles,

please email: Julia.Zhang@ubmsinoexpo.com to motify or remove the content.