"We’re delighted to have completed recruitment in this study, which is the first step in our phase III program on difficult-to-treat and resistant hypertension, despite the challenges posed by the health crisis,"
Eligible patients with difficult-to-treat or resistant hypertension have been randomized in 69 hospitals across
According to the study’s protocol, patients received, in addition to their current treatment including at least two classes of antihypertensives, firibastat at the dose of 500 mg BID3 or a placebo for three months. The study’s primary endpoint is the reduction in AOBP4 measurements after three months of treatment compared to baseline values at randomization. Its secondary endpoints include ambulatory blood pressure measurements, the percentage of patients at target blood pressure and blood concentrations of several biomarkers.
No treatment-related serious adverse event has yet been reported. The prevalence of allergic skin reactions is consistent with that observed in the NEW-HOPE study. The trial has been overseen by an independent data monitoring committee (IDMC) that has consistently recommended continuing it with the protocol unchanged at every evaluation.
With the last visit of the last included patient coming after three months of treatment and a month of post-treatment follow-up, the initial results of the phase III pivotal study FRESH are expected in late
REFRESH, the second phase III long-term efficacy and safety pivotal study with the once-a-day formulation of firibastat and necessary for registering the product, is continuing normally, providing confirmation that the marketing authorization application will be submitted in the third quarter of 2023.
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1 Uncontrolled patients despite two classes of antihypertensives, including one diuretic, at the maximum tolerated doses
2 Uncontrolled patients despite at least three classes of antihypertensives, including one diuretic, at the maximum tolerated doses
3 BID: Bis in Die (twice daily)
4 AOBP: Automatic Office Blood Pressure
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