Grifols clinical trial shows positive results for post-polio patients

Immunoglobulin therapy improves mobility in phase 2/3 study

Grifols has announced positive results from its phase 2/3 clinical trial evaluating the efficacy and safety of intravenous immunoglobulin (IVIG) to treat post-polio syndrome (PPS). The study showed significant improvement in mobility for patients receiving IVIG compared to placebo.

The trial, conducted over one year, met its primary endpoint of improved physical performance in the two-minute walk distance (2MWD). Patients receiving monthly IVIG infusions demonstrated a statistically significant improvement in 2MWD compared to those on placebo.

IVIG, specifically Flebogamma® 5% DIF, was found to be safe and well-tolerated, with a similar safety profile to other IVIG treatments. The study involved 191 participants, with the majority experiencing symptoms primarily in their legs.

In addition to improved 2MWD, patients treated with IVIG also showed greater endurance in the six-minute walk distance (6MWD). The treatment demonstrated a 29.16-meter improvement in 6MWD compared to placebo.

PPS can develop decades after an initial polio infection, with symptoms worsening over time. An estimated 12-to-20 million polio survivors worldwide are at risk of developing PPS symptoms, with 25% to 40% likely to be affected.

“There are no medications indicated for PPS, and therapies are limited to supportive measures,” said Dr Jörg Schüttrumpf, Grifols Chief Scientific Innovation Officer. “These results show a meaningful physical accomplishment, providing patients with more freedom of movement.”

Dr Frans Nollet, a principal investigator in the study, said: “This study is great news since it proves that the ongoing decline in physical functioning due to PPS can be halted, and even improved.”