Date: 2016-06-30
Type of
information: Initiation of the trial
phase: 2a
Announcement: initiation of the trial
Company: Quantum Genomics (France)
Product: QGC001
Action
mechanism:
- enzyme inhibitor/ Brain Aminopeptidase A inhibitor. QGC001 is a Brain Aminopeptidase A inhibitor (BAPAI) product. This candidate is a prodrug that delivers in the brain the EC33 product, a selective and specific inhibitor of Aminopeptidase A, thus preventing the production of Angiontensin III in the brain. Several preclinical studies and two clinical studies have been conducted already using QGC001 to assess its pharmacokinetic, pharmacodynamic, safety and tolerance parameters in animals and humans.
Disease: chronic heart failure
Therapeutic
area: Cardiovascular diseases
Country: France, Germany, Netherlands, Norway, Poland, UK
Trial
details:
- This phase II randomized, placebo controlled, double-blind, multi-centre study is assessing the safety and the efficacy of incremental doses of QGC001 in patients upon discharge from hospital admission for worsening chronic heart failure with left ventricular systolic dysfunction. (NCT02780180)
Latest
news:
- • On June 30, 2016, Quantum Genomics announced the initiation of its Phase IIa multicentric clinical trial of GQC101, entitled QUID HF (QUantum Genomics Incremental Dosing in Heart Failure), for the treatment of patients with chronic heart failure.
- The first three clinical centres of the European trial have been opened in France and Norway. Faiez Zannad, Professor of Therapeutic Cardiology at the University of Lorraine (Nancy CHU), is the principal investigator and is directing the trial in collaboration with Dr.Olivier Madonna, Chief Medical Officer at Quantum Genomics.
- The randomized double-blind trial plans to enroll a total of 75 patients to test the effects of QGC101, at multiple doses in chronic heart failure sufferers with altered cardiac ejection fraction. The first clinical centres have been initiated at Louis Pradel Hospital in Lyon (France), Stavanger University Hospital in Stavanger (Norway) and Laennec Hospital in Nantes (France). The sites were opened after obtaining the regulatory authorizations in France and Norway in the spring of 2016, a process that is currently continuing in other European countries. The trial is designed to be conducted in 10 hospitals in six countries.
Is
general: Yes
