Results enable initiation of additional hypertension studies for lead candidate
Company to conduct a U.S. Phase II trial in targeted patient population based on FDA advice
Quantum Genomics (Alternext - FR0011648971 - ALQGC), a biopharmaceutical company focused on developing new therapies for unmet medical needs in the field of cardiovascular diseases, today announced positive top-line results from its Phase IIa trial of lead candidate QGC001 in patients with hypertension (high blood pressure).
The data show positive signals on several endpoints, in particular on the primary endpoint of the study, specifically a drop in daytime systolic blood pressure measured as ambulatory pressure in hypertensive patients, treated with QGC001 as compared with placebo. This positive result is confirmed by an in depth multivariate analysis.
In this double-blind crossover study, a total of 34 patients with moderate Grade I to II hypertension were randomized, and received two 28-day sequences alternating the investigational product QGC001 versus placebo, separated by a 14-day washout (no treatment) period.
Dr. Olivier Madonna, Quantum Genomics Chief Medical Officer, said:
"It is very encouraging for the lead product candidate in our new class of anti-hypertensive therapeutics to obtain these results in its first Phase II clinical trial. This study, which evaluated general hypertensive patients reflective of a major patient population in the EU and U.S., reinforces our QGC001 development strategy and allows us now to initiate a new Phase II trial in hypertensive patients requiring new treatment options to effectively control their high blood pressure.”
The full results of the study will be presented at a major medical meeting. In this respect, the Company is targeting the next European Society of Hypertension meeting which will take place in June 2017 in Milan.
In addition, Quantum Genomics announced that a Pre-Investigational New Drug (IND) meeting took place with the U.S. Food and Drug Administration (FDA) in Washington. The FDA has reviewed and analyzed the entire QGC001 documentation, including all preclinical and clinical data available to date, particularly the Phase IIa trial methodology and efficacy and tolerance data. Based on the information, the FDA has advised the Company on the design of a Phase II trial to be conducted in the United States to evaluate QGC001 in a targeted population of hypertensive patients. Quantum Genomics plans to submit an IND application for the trial in the first half of 2017.
The company is also evaluating the possibility of further clinical trials in Europe and Asia.
Lionel Ségard, Chairman & CEO of Quantum Genomics, commented:
"The FDA's encouraging feedback and insights are significant for Quantum Genomics, and represent excellent news for patients with inadequately controlled hypertension or for whom treatment has failed. The Phase IIa results and ongoing discussions with the FDA reinforce our commitment to developing QGC001 as a new anti-hypertensive drug candidate for a targeted patient population, while continuing our parallel development for the treatment of heart failure."
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 high blood pressure and heart failure.
Quantum Genomics 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.
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