Quantum Genomics announces the end of patient recruitment for the pivotal Phase III study, FRESH
Quantum Genomics (Euronext Growth – FR0011648971 – ALQGC)
a biopharmaceutical company specializing in the development of a new class of drugs that act directly on the brain to treat high blood pressure and heart failure, announces today that it has enrolled all of the patients planned in its pivotal phase III study , FRESH, to assess the efficacy of firibastat in the treatment of difficult-to-treat high blood pressure
[1]
and resistant
[2]
.
”
We are very pleased to have completed the recruitment of this study which represents the first step of our phase III program in difficult to treat and resistant hypertension, despite the difficulties encountered due to the health crisis.
announced Jean-Philippe Milon, CEO of Quantum Genomics.
Eligible patients with difficult-to-treat or resistant hypertension were randomized to 69 hospitals in Europe (France, Germany, Poland, Spain, Hungary, Bulgaria and the Czech Republic), Canada, the United States and Latin America (Brazil and Mexico).
According to the study protocol, patients received for 3 months, in addition to their ongoing treatment comprising at least two classes of antihypertensive drugs, either firibastat at a dose of 500 mg BID
[3]
or a placebo treatment. The primary endpoint of the study is the reduction in systolic blood pressure measured automatically in the medical office (AOBP
[4]
) after 3 months of treatment compared to the initial value measured on the day of randomisation. The secondary endpoints of the study notably include ambulatory blood pressure measurements, the percentage of patients at the blood pressure target, as well as the blood concentrations of several biomarkers.
To date, no serious adverse events related to the treatment have been reported. The rate of occurrence of skin allergies is consistent with what was observed in the NEW-HOPE study. The study was monitored by an independent data review committee (IDMC) which always recommended continuing the study without modification of the protocol after each evaluation.
The last visit of the last patient included taking place after 3 months of treatment and one month of follow-up after stopping treatment, the announcement of the first results of the pivotal phase III study, FRESH, is expected at the end of October 2022 compatible with a presentation at the American Heart Association (AHA) convention in Chicago November 5-7, 2022.
The REFRESH study, the second pivotal phase III study of long-term efficacy and safety with the once-daily formulation of firibastat and required for product registration, is continuing normally, which makes it possible to confirm the filing of the marketing authorization application file in the third quarter of 2023.
About Quantum Genomics
Quantum Genomics is a biopharmaceutical company specializing in the development of a new class of cardiovascular drugs, based on the mechanism of inhibition of brain Aminopeptidase A (Brain Aminopeptidase A Inhibition or BAPAI). The only company in the world to pursue this innovative approach directly targeting the brain, it relies on more than twenty years of research from the University of Paris-Descartes and the INSERM/CNRS laboratory directed by Dr. Catherine Llorens-Cortès at France secondary school. Quantum Genomics thus aims to develop innovative treatments for complicated or even resistant arterial hypertension (about 30% of patients are poorly controlled or fail treatment), and heart failure (one out of two diagnosed patients dies within five years).
Based in Paris and New York, the company is listed on the Euronext Growth market in Paris (FR0011648971 – ALQGC) and registered on the American market OTCQX (symbol: QNNTF).
More information on www.quantum-genomics.com, our Twitter and Linkedin accounts
contacts
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Quantum Genomics | |
|
Communication building (EUROPE) | |
Financial communication and media | |
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Mike Tattory |
[1]
Patients not controlled despite two classes of antihypertensives, including a diuretic, at maximum tolerated doses
[2]
Patients not controlled despite at least three classes of antihypertensive, including a diuretic, at maximum tolerated doses
[3]
BID: Bis in Die (twice a day)
[4]
AOBP: Automatic Office Blood Pressure
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