Grifols posts positive Phase II/III trial of Flebogamma

Spanish plasma-derived medicines specialist Grifols (MCE: GRF) has announced positive results from its Phase II/III clinical trial evaluating the efficacy and safety of its intravenous immunoglobulin (IVIG) to treat patients with post-polio syndrome (PPS), demonstrating a significant improvement in distance walked compared to placebo.

This study met its primary endpoint of enhanced physical performance in the two-minute walk distance (2MWD) after the one-year treatment period. Patients who received monthly IVIG infusions of 1g/kg showed a statistically-significant improvement in 2MWD versus placebo. The least squares mean 2MWD change from baseline at week 52, after adjusting for differences between groups, was 12.75 meters, equating to a mean improvement of 6.07 meters over placebo.

The company noted that the immunomodulatory properties of IVIG – in this case Flebogamma 5% DIF (immune globulin intravenous [human]) – are believed to have a role in potentially improving this disabling condition.