Officials with Kamada have announced that the pivotal phase 2/3 clinical trial of its human rabies immune globulin (IgG, KamRAB/KedRAB) as a post-exposure treatment for rabies successfully met its primary endpoint of non-inferiority when measured against an IgG reference product.
The trial was a prospective, randomized, double-blind, non-inferiority study, which evaluated pharmacokinetic (PK) parameters of serum anti-rabies IgG levels at different time points and assessed whether the IgG interfered with the development of self-active antibodies.
In addition, the trial also assessed safety and tolerability profile. The study enrolled 118 healthy subjects who were injected with human rabies immune globulin and an active vaccine per standard of care. Anti-rabies titer was measured on Day 14, as well as on additional time points for secondary endpoints. The primary endpoint was non-inferiority to an IgG reference product with a -10% margin.
Top-line results showed that the primary endpoint of non-inferiority was met with a difference of -1.8% between the two therapies with variability between -8.2% and 3.1% (90% CI). Kamada’s IgG has shown to be a safe and well-tolerated treatment with no drug-related serious adverse events.
Following the results of this trial, Kamada intends to file a Biologics License Application (BLA) with the Food and Drug Administration (FDA) for its human rabies IgG in mid-2016. It will be branded as KedRAB in the U.S. upon approval.
KamRAB/KedRAB is a protein therapeutic derived from hyper-immune plasma containing high levels of antibodies from donors that have been previously exposed to rabies.
This article originally appeared on MPR