Quantum Genomics Announces the End of Patient Recruitment for its Phase III Pivotal Study FRESH
Quantum Genomics (Euronext Growth - FR0011648971 - ALQGC), a biopharmaceutical company specializing in the development of a new drug class directly targeting the brain to treat hypertension and heart failure, announces today that it has recruited all planned patients in its phase III pivotal study FRESH, which aims to evaluate firibastat's efficacy in the treatment of difficult-to-treat[1] and resistant[2] hypertension.
"We're delighted to have completed recruitment in this study, which is the first step in our phase III program on difficult-to-treat and resistant hypertension, despite the challenges posed by the health crisis," Jean-Philippe Milon, CEO of Quantum Genomics, announced.
Eligible patients with difficult-to-treat or resistant hypertension have been randomized in 69 hospitals across Europe (France, Germany, Poland, Spain, Hungary, Bulgaria and Czechia), Canada, the United States and Latin America (Brazil and Mexico).
According to the study's protocol, patients received, in addition to their current treatment including at least two classes of antihypertensives, firibastat at the dose of 500 mg BID[3] or a placebo for three months. The study's primary endpoint is the reduction in AOBP[4] measurements after three months of treatment compared to baseline values at randomization. Its secondary endpoints include ambulatory blood pressure measurements, the percentage of patients at target blood pressure and blood concentrations of several biomarkers.
No treatment-related serious adverse event has yet been reported. The prevalence of allergic skin reactions is consistent with that observed in the NEW-HOPE study. The trial has been overseen by an independent data monitoring committee (IDMC) that has consistently recommended continuing it with the protocol unchanged at every evaluation.
With the last visit of the last included patient coming after three months of treatment and a month of post-treatment follow-up, the initial results of the phase III pivotal study FRESH are expected in late October 2022 for presentation at the American Heart Association (AHA) congress in Chicago from November 5 to 7, 2022.
REFRESH, the second phase III long-term efficacy and safety pivotal study with the once-a-day formulation of firibastat and necessary for registering the product, is continuing normally, providing confirmation that the marketing authorization application will be submitted 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 Brain Aminopeptidase A Inhibition (BAPAI) mechanism. It is the only company in the world to pursue this innovative approach directly targeting the brain, founded upon more than twenty years of research work by Paris-Descartes University and the INSERM/CNRS laboratory led by Dr. Catherine Llorens-Cortès at the Collège de France. Quantum Genomics thus aims to develop innovative treatments for complicated or even resistant hypertension (in approximately 30% of patients it is poorly controlled, or treatment failure occurs), and heart failure (one in two patients diagnosed dies within five years).
Based in Paris, the company is listed on the Euronext Growth market in Paris (FR0011648971 - ALQGC) and is registered on the US OTCQX market (symbol: QNNTF).
Find out more at www.quantum-genomics.com, or on our Twitter and LinkedIn accounts.
Contacts
| Quantum Genomics | ||
| contact@quantum-genomics.com | ||
| Edifice Communication (EUROPE) | ||
| Financial and media communication quantum-genomics@edifice-communication.com | ||
| LifeSci (USA) | ||
| Mike Tattory Media communication +1 (646) 751-4362 - mtattory@lifescipublicrelations.com |
[1] Uncontrolled patients despite two classes of antihypertensives, including one diuretic, at the maximum tolerated doses
[2] Uncontrolled patients despite at least three classes of antihypertensives, including one diuretic, at the maximum tolerated doses
[3] BID: Bis in Die (twice daily)
[4] AOBP: Automatic Office Blood Pressure
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https://www.actusnews.com/documents_communiques/ACTUS-0-74479-cp-dernier-patient-fresh-en.pdf
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