Date: 2017-09-05
Type of
information: Clinical trial authorisation
phase: 2
Announcement: clinical trial authorization
Company: Quantum Genomics (France)
Product: QGC001
Action
mechanism:
- enzyme inhibitor/Brain Aminopeptidase A inhibitor (BAPAI). 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: arterial hypertension
Therapeutic
area: Cardiovascular diseases
Country: USA
Trial
details:
Latest
news:
- • On September 5, 2017, Quantum Genomics announced that the FDA cleared its Investigational New Drug (IND) application to begin the NEW-HOPE large Phase II clinical trial for QGC001 in hypertensive patients. The trial 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. 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.
- • On June 28, 2017, Quantum Genomics announced the design of its next Phase II trial in arterial hypertension, NEW-HOPE ("Novel Evaluation With QGC001 in Hypertensive Overweight Patients of Multiple Ethnic Origins"), in arterial hypertension (HTN), with QGC001, on 250 high cardiovascular risk patients. At the end of this trial – the results of which are expected in the first half of 2019 – a Phase III clinical trial could then be initiated with QGC001. The trial will be launched this fall and will mainly target a population of hypertensive patients with a particular profile known as "Low Renin High Vasopressin" (LRHV) and that often has resistant HTN.
- The trial will be conducted in 25 centers in the United States, on 250 high-risk hypertensive patients (overweight and with higher baseline blood pressure than in the previous trial), including a significant proportion of patients being from minorities. After two weeks of halting all hypertensive treatment, the patients will receive QCC001 treatment
for eight weeks. The initial QGC01 dose, 250 mg twice a day, will be increased if necessary to 500 mg twice a day. A diuretic treatment (25 mg hydrochlorothiazide) may be added, as this is often the treatment protocol for this type of patients.
The primary efficacy criterion will be a drop in office blood pressure after eight weeks. 24hrAmbulatory blood pressure measurements (ABPM) will also be recorded after eight weeks. Response-rate will be measured, as well as predictive factors for response. Safety data will also be monitored.
Is
general: Yes
