QUANTUM GENOMICS : Regulatory authorisations received in France to begin Phase IIa multicentric European trial for heart failure

information fournie par Actusnews •26/04/2016 à 18:00

Quantum Genomics (Alternext - FR0011648971 - ALQGC) , a biopharmaceutical company with the mission of developing new therapies for unmet medical needs in the field of cardiovascular diseases, announces it has obtained authorisations from ANSM (the French national drug and health products safety agency) and CPP (the French consumer protection agency) to begin the Phase IIa trial for the treatment of heart failure (QGC101 program).

Dubbed Quid HF (Heart Failure ), this Phase IIa multicentric clinical trial on patients suffering from heart failure will be conducted in a number of European countries, including France . These regulatory authorisations for France will allow actual trials in the country's leading medical centers to be launched by mid-2016, more than six months ahead of the initial schedule. Quantum Genomics is also beginning to receive regulatory authorisations for other European countries.

Faiez Zannad, Professor of Therapeutic Cardiology at the University of Lorraine (Nancy CHU teaching hospital), will coordinate the Quid HF trial , in collaboration with Doctor Olivier Madonna, Chief Medical Officer at Quantum Genomics. Professor Zannad has previously conducted major international clinical trials for heart failure.

Quantum Genomics also confirms that the Phase IIa clinical trials for high blood pressure (QGC001 program) were completed in April 2016, as planned. The results will be released in the third quarter of 2016.

Heart failure is a major public health problem with a persistent urgent need for new therapeutic treatments. Despite some medical advances, the vital prognosis associated with heart failure is very poor as more than 50% of people diagnosed with heart failure die within five years.

Heart failure today affects some 5.8 million people in the United States alone and more than 23 million worldwide, according to American Heart Association data. Direct and indirect annual costs connected with heart failure worldwide in 2012 were an evaluated 108 billion dollars. The global market for heart failure drugs was estimated at 39 billion dollars in 2015.