BioCentury
ARTICLE | Clinical News

Velo begins Phase IIb/III for digoxin immune fab to treat severe preeclampsia

June 9, 2017 7:52 PM UTC

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) said Velo Bio LLC (Morrisville, N.C.) began a double-blind, U.S. Phase IIb/IIIa trial to evaluate digoxin immune fab (DIF, DigiFab) in about 200 antepartum women with severe preeclampsia. AMAG has an exclusive option to acquire worldwide rights to the product from Velo following completion of the trial. AMAG said it plans to submit an NDA to FDA in 2019.

Patients will receive placebo or 3.2 mg/kg IV digoxin immune fab every 6 hours for 4 days. The trial’s primary endpoint is proportion of babies who have severe intraventricular hemorrhage, necrotizing enterocolitis or death at 36 weeks post-menstrual age. Its secondary endpoints are change in serum creatinine, incidence of pulmonary edema, proportion of mothers with modified early obstetric warning score of ≥3 at 24 hours post-final dose, delivery latency and anti-hypertensive drug use during treatment...