Quantum Genomics Receives FDA Clearance of IND Application for QGC001

Quantum Genomics Receives FDA Clearance of IND Application for QGC001

Company to Launch NEW-HOPE, a targeted Phase II clinical trial in Hypertension in the U.S.

Paris & New York, September 5, 2017

Quantum Genomics (Euronext Growth − FR0011648971 − ALQGC; OTCQX: QNNTF), a biopharmaceutical company with the mission of developing new therapies for unmet medical needs in the field of cardiovascular diseases, announced today that the U.S Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application to begin a large Phase II clinical trial for QGC001, Quantum Genomics lead asset, in hypertensive patients.

The upcoming clinical study, titled Novel Evaluation with QGC001 in Hypertensive Overweight Patients of Multiple Ethnic Origins (NEW-HOPE), will be conducted across 25 leading hospitals in the U.S. and recruit 250 hypertensive and overweight patients. At least 50% of the recruited patients will be from ethnic minorities in the U.S., whom are found to be more likely to suffer from “Low Renin High Vasopressin” hypertension. Based on experimental results, Quantum Genomics aims this specific patients profile which has a higher cardiovascular risk.

Lionel Segard, Chairman and Chief Executive Officer of Quantum Genomics, commented:

“Receiving the green light from the FDA to proceed with running clinical trials in the U.S. reflects the commitment we hold in providing LRHV hypertensive patients an effective treatment. The FDA reviewed both our IND application (including all preclinical pharmacology and toxicity as well as phase I and IIa studies in humans) and the NEW-HOPE study protocol before issuing clearance, which further strengthens shareholder value and confidence.”

Quantum Genomics will host an Investigator's Meeting on September 21 and 22 in Chicago, Illinois, to prepare each trial site for operating and managing the study. The principal investigator will be Professor Keith C. Ferdinand. The first patient is expected to be enrolled in the fourth quarter of 2017 and preliminary results are expected in the first half of 2019.

Source: Actusnews