Grifols’ Albutein misses primary Phase III endpoint

Spanish plasma-based medicines maker Grifols (MCE: GRF) has announced disappointing top-line data from its Phase III PRECIOSA clinical trial evaluating the potential of long-term albumin treatment with Grifols Albutein on patients with decompensated cirrhosis and ascites, sending its share down 2.4% to 9.27 euros on Friday.

Although the trial did not meet its primary endpoint of one-year transplant-free survival, Grifols noted that an improvement in transplant-free survival, mortality and disease-related complications was observed for patients treated with Albutein 20% plus standard medical treatment (SMT) compared with patients receiving only SMT.

Further, a notable improvement in time-to-liver transplant or death at three months was observed for the study treatment plus SMT group of patients, when compared with the patients treated only with SMT. The safety and tolerability profile was favorable, and there were no adverse-reaction risks, beyond what is already on label, that would limit adoption of the therapy.