Company Announces FDA Acceptance of Investigational New Drug Application to Initiate PRESERVE-1— enrollment to begin mid-2014
March 31, 2014
rEVO Biologics Inc., a subsidiary of LFB SA, today announced the initiation of the Phase 3 clinical program for ATryn® [antithrombin (Recombinant)] for the treatment of preeclampsia in pregnant women during the 24th to 28th week of pregnancy. Preeclampsia at this stage of pregnancy is rare and extremely serious, occurring in a subset of all preeclampsia patients. The objective of the PRESERVE-1 trial is to assess whether ATryn prolongs pregnancy in mothers with early-onset preeclampsia and consequently improves the health of their babies.
Preeclampsia is an area of high unmet medical need, particularly when it occurs early in pregnancy. Previously, rEVO announced the submission of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) for ATryn for the treatment of early-onset preeclampsia in pregnant women. The FDA has now indicated that the PRESERVE-1 trial may proceed.
“We are pleased to initiate the PRESERVE-1 clinical trial for the management of early-onset preeclampsia. This is an important step forward in our pursuit to bring a novel treatment for early-onset preeclampsia where nothing exists today,” said Yann Echelard, PhD, President, rEVO Biologics. “There is an incredible need for treatments to manage preeclampsia, particularly when it occurs early in pregnancy. If proven to be safe and effective, ATryn will be the first drug specifically indicated for the management of preeclampsia in pregnant women during the 24th to 28th week of pregnancy to prolong gestation and decrease fetal and neonatal morbidity and mortality.”
Preeclampsia is a life-threatening condition that occurs in approximately six to eight percent of all pregnancies and typically occurs after the twentieth week of pregnancy. The cause of preeclampsia is unknown, but the number of cases is growing. In the U.S., the incidence of the disorder has increased by approximately 25 percent since 1987. Preeclampsia is particularly devastating when it occurs very early during the pregnancy, as it leads to the birth of severely premature babies. At present, delivery of the baby is the only known treatment for preeclampsia.
About the PRESERVE-1 Clinical Trial
PRESERVE-1(Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia) is a Phase 3, randomized, double-blind, placebo controlled trial of 120 patients assessing the safety, efficacy and pharmacokinetics (PK) of ATryn in patients who are being expectantly managed for early-onset preeclampsia.
Efficacy will be assessed by comparing the difference in gestational age from the time of randomization into the trial until delivery of the baby in women given ATryn to those given placebo. The effect of ATryn on neonatal clinical outcomes will also be assessed.
See the press release here.