LFB Biotechnologies’ subsidiary rEVO Biologics has enrolled the first patient in its Phase III clinical trial of ATryn to treat preeclampsia.
ATryn is a recombinant antithrombin used for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.
The PRESERVE-1 trial seeks to assess whether ATryn prolongs pregnancy in mothers with early onset preeclampsia and consequently lower the neonatal mortality and disability rates caused by this condition.
Around 120 patients will be randomised in the double-blind, placebo-controlled Phase III trial to evaluate the safety, efficacy and pharmacokinetics (PK) of ATryn, in patients who are being expectantly managed for early onset preeclampsia.
The first patient in the trial was enrolled at the University of Alabama, Birmingham, by professor of Obstetrics and Gynecology Dr Alan Tita and team.
Tita said: "As a physician faced with the difficult challenge of managing preeclampsia early in pregnancy, I see first-hand the significant need for new medicines to safely extend pregnancy and give a baby more time to develop in utero.
"Our team is thrilled with the opportunity to participate in PRESERVE-1, an important Phase III trial designed to assess the potential benefits of ATryn in a clear area of unmet medical need."
The trial’s primary objective is to evaluate the efficacy, safety and pharmacokinetics of ATryn for treatment of early onset preeclampsia when used together with expectant management, the current standard of care.
According to rEVO, efficacy will be evaluated by comparing the difference in gestational age from the time of randomisation into the trial until delivery of the baby in women given ATryn to those given placebo.
The trial, which is currently enrolling patients in the US, will also assess the effect of ATryn on neonatal clinical outcomes.
rEVO Biologics president and CEO Yann Echelard said: "With our trial of ATryn in early onset preeclampsia now underway, we look forward to having clinical investigators across the country join us in assessing ATryn as a treatment option for a subset of women with early onset preeclampsia who are faced with delivering a severely premature baby."