Granata Bio has completed participant screening in its Phase III GRACE trial of Granata Bio human menopausal gonadotropin (GB-hMG) in women who are undergoing in vitro fertilisation (IVF).
The biopharmaceutical developer expects data from the study to support a potential biologics licence application (BLA) for GB-hMG.
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The randomised, multi-centre, placebo-controlled, double-blind trial screened over 750 women across fertility clinics in the US. Granata Bio expects to enrol around 625 participants aged between 18 and 42 years across two cohorts.
With screening concluded, the clinical programme is advancing through active treatment, embryo transfer, and pregnancy follow-up, with the first live birth anticipated by the end of this year.
Granata Bio CEO Evan Sussman said: “15 exceptional fertility clinics chose to participate in GRACE, and their investigators and study teams have done a tremendous job identifying, screening and enrolling these cohorts.
“We’re grateful to everyone who considered participating in GRACE, and we hope that those who enrolled have great outcomes, both in the study and in building their families.”
Granata Bio scientific affairs head Barbara Cometti said: “GRACE is designed to evaluate the cumulative live birth rate following a single stimulation cycle with Granata’s GB-hMG.
“This means following participants throughout their entire treatment journey, from ovarian stimulation through all available embryo transfers.
“While this approach requires time, it allows us to assess the outcome that ultimately matters most: the chance of achieving a live birth.”
The GRACE study is designed to assess the safety and efficacy of GB-hMG in developing multiple follicles, achieving pregnancy, and supporting cumulative live births during an assisted reproductive technology (ART) cycle.
Enrolled subjects will proceed through planned treatment and follow-up periods, with Granata Bio intending to provide further updates as the research continues.
Founded in 2018, Granata Bio is a biopharmaceutical company focused on reproductive health. The business develops and accelerates fertility therapies intended to broaden treatment options, expand access, and improve affordability.
