Quantum Genomics Enrolls First Patient in Its Pivotal Phase III FRESH Trial of Firibastat in Difficult-to-treat and Resistant Hypertension

PARIS and NEW YORK, July 13, 2020 (GLOBE NEWSWIRE) -- Quantum Genomics (Euronext Growth - FR0011648971 - ALQGC), a biopharmaceutical company specializing in developing a new drug class that directly targets the brain to treat difficult-to-treat and resistant hypertension and heart failure, today announced the enrollment of the 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.

“We are thrilled to enroll the first patient in our pivotal phase III study of firibastat in patients with difficult to treat and resistant hypertension,” said Jean-Philippe Milon, chief executive officer of Quantum Genomics. “We believe firibastat has the potential to meaningfully improve the treatment regimen for this large, and currently underserved population of patients and we look forward to top-line results by the end of 2021.”

The FRESH study is a randomized, double-blind, placebo-controlled pivotal phase III study, which will be conducted in approximately 70 hospitals worldwide and enroll 502 patients with difficult-to-treat or resistant hypertension. Patients will receive either 500mg of firibastat or placebo twice daily for 3 months, in addition to their current treatment. The primary endpoint will be the reduction in systolic automated office blood pressure (AOBP) from baseline.

The study is being conducted in Europe (France, Germany, Poland, Spain and the Czech Republic), Canada, the United States, and Latin America (Brazil and Mexico), with the support of two contract research organizations: PRA Health Sciences in Europe, Canada, the U.S. and Azidus in Latin America.

The Company received all necessary ethical and regulatory approvals to conduct its trial in the majority of countries and has been able to open the first centers, while taking all necessary safety measures and precautions for trial participants and facility workers amidst the ongoing COVID-19 pandemic.

The FRESH Phase III trial design was based on results of the previously completed Phase II NEW HOPE study, which demonstrated the efficacy of firibastat in a hypertensive and high cardiovascular risk patient population, 38% of which was of African American descent, and the majority of which was obese: two patient populations that are frequently affected by resistant hypertension, and have disease states that are often in the difficult-to-treat category. The company received FDA’s concurrence on the trial design in late 2019.