Quantum Genomics (Alternext - FR0011648971 - ALQGC), a biopharmaceutical company with the mission of developing new treatments for unmet medical needs in the field of cardiovascular diseases, today announced positive results from preclinical studies of QGC001, its lead monotherapy candidate for the treatment of hypertension, demonstrating the absence of genotoxicity in animals and no risk of phototoxicity.
Results from these preclinical studies, conducted using FDA-recommended tests on murine models, confirmed QGC001 did not induce damage to the chromosomes or the mitotic apparatus of rat bone marrow cells after orally administering doses of up to 2000 mg/kg/day, which are expected to exceed a therapeutically relevant dose. Additionally, QGC001 was determined to be non-phototoxic in the in vitro neutral red uptake phototoxicity test using the murine Balb/c 3T3 cell line recommended by the U.S. Food and Drug Administration (FDA).
Lionel Ségard, Chairman & Chief Executive Officer of Quantum Genomics, commented,
"We are pleased to report these positive results which demonstrate the photosafety of QGC001 and its absence of genotoxicity in animals, even at high dose levels. We expect to get, in the second quarter 2017, additional data from toxicity studies conducted in rats and dogs, and thus complete the nonclinical program we presented to the FDA in a pre-IND meeting.”
Quantum Genomics remains on track to submit in the coming months an Investigational New Drug (IND) application to initiate a phase II clinical study in targeted population of hypertensive patients in the United States.
QGC001 has already been examined in three completed clinical trials and detailed results from the recently-completed 34-person phase IIa study will be presented at the 27th annual European Society of Hypertension meeting in June in Milan.
QGC001, Quantum Genomics' lead Brain Aminopeptidase A Inhibitor (BAPAI) candidate, is a first-in-class standalone treatment for hypertension. Functionally, QGC001 is a prodrug of EC33, a selective and specific inhibitor of Aminopeptidase A that prevents the production of Angiotensin III in the brain.
Due to its unique action mechanism, QGC001 is an improved therapeutic approach which interferes with mechanisms involved in the genesis and control of high blood pressure in hypertensive patients, especially in those who exhibit a particular hormonal profile characterized by a low renin and a high vasopressin concentration (Low Renin High Vasopressin (LRHV) profile).
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|ABOUT QUANTUM GENOMICS
Quantum Genomics is a biopharmaceutical company with the mission of developing new therapies for unmet medical needs in the field of cardiovascular diseases, especially hypertension and heart failure.
The Company is developing a new therapeutic approach based on BAPAI (Brain Aminopeptidase A Inhibition). This is the result of more than 20 years of academic research in the laboratories of the Collège de France, INSERM, CNRS and the University of Paris Descartes.
Quantum Genomics is listed on the Alternext market in Paris (isin code FR0011648971, Ticker ALQGC).
The Company has offices in Paris, France, and New York, NY, USA. For more information, please visit www.quantum-genomics.com.