Quantum Genomics gets Approval from the Patients' Protection Committee
QGC001 is the first of a new class of drugs that aim to treat high blood pressure (HBP) - also called hypertension. The application of this First-in-Human clinical trial has been submitted to the French Agency for Safety of Health Products (AFSSAPS).
This clinical trial will be a single ascending oral dose, double-blind and placebo-controlled Phase I study. It will aim at assessing the overall safety, tolerability and pharmacokinetics of QGC001 in healthy volunteers.
An exploratory study conducted in parallel, in partnership with the Centre d'Investigations Cliniques 9201/APHP-INSERM of the Hôpital Européen Georges Pompidou (Paris, France) and thanks to the financial support from the French National Agency for Research (ANR), will aim at identifying relevant biomarkers to support the next coming phases of the clinical development.
"This approval from the "Comité de Protection des Personnes" is a major step in the development of QGC001 which reinforces the very good preclinical results, says Lionel Segard, President and CEO of Quantum Genomics. QGC001 is a breakthrough innovation that will bring hope to patients with a specific profile, especially those who are usually not properly treated for their hypertension despite several drugs and/or suffer from important side effects.
Quantum Genomics is looking forward to starting the clinical trials in the first half of 2012, as soon as we get the approval from AFSSAPS."