Kamada's Human Rabies Immune Globulin Meets Primary Endpoint In Phase 2/3 Trial

(RTTNews) - Kamada Ltd. (KMDA) said that the pivotal Phase 2/3 clinical trial with the Company's human rabies immune globulin (IgG or KamRAB or KedRAB) therapy as a post-exposure treatment for rabies successfully met the trial's primary endpoint of non-inferiority when measured against an IgG reference product.

The Company expects to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration or FDA in mid-2016.

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% Confidence limit). Results showed that Kamada's IgG was safe and well tolerated with no drug-related Serious Adverse Events (SAEs) experienced.

KamRAB is the brand name for Kamada's human rabies immune globulin currently marketed for this indication in 10 countries worldwide. Kamada has a strategic agreement with Kedrion S.p.A for the clinical development and marketing of its IgG product, which will be branded as KedRAB in the U.S., subject to receiving marketing approval from the FDA.