March 4, 2014
Kamada Ltd., a plasma-derived protein therapeutics company, focused on orphan indications, announces that it has completed enrollment in its U.S. Phase 2/3 clinical trial of KamRAB® as a post-exposure prophylaxis (PEP) for rabies.
KamRAB is Kamada’s human rabies immune globulin, currently marketed for this indication in 6 countries worldwide. Kamada has a strategic agreement with Kedrion S.p.A for the clinical development and marketing of KamRAB in the U.S.
The Phase 2/3 clinical trial is a prospective, randomized, double-blind, non-inferiority study of 118 healthy subjects to evaluate the safety and effectiveness of KamRAB. The study assesses whether KamRAB interferes with the development of self-active antibodies.
The primary and secondary endpoints of this study are pharmacokinetic (PK) parameters of anti-rabies IgG levels in serum at different time points. In addition, safety and tolerability are assessed. Detailed information about this study is available at www.clinicaltrials.gov.
“Completion of recruitment for this Phase 2/3 clinical study with KamRAB brings us one step closer to expanding access to patients in the U.S., where there are approximately 40,000 post-exposure prophylaxis given each year… We look forward to completing this pivotal study in the coming months and, pending a favorable outcome, to filing a submission for approval with the FDA thereafter.”
“According to the World Health Organization, about 10 million people worldwide require medical treatment against rabies every year after being bitten by animals suspected of rabies infection. In the U.S., there is currently only one significant provider of anti-rabies immunoglobulin and we believe that healthcare providers may seek to diversify their source of supply if a competing high-quality product were approved for sale,” David Tsur, Co-founder and Chief Executive Officer of Kamada
Rabies is a preventable viral disease of mammals most often transmitted through exposure to a rabid animal. KamRAB is a prophylactic treatment against rabies infection that is administered to patients after exposure to an animal suspected of being infected with rabies. KamRAB is a protein therapeutic derived from hyper-immune plasma, which is plasma that contains high levels of antibodies from donors that have been previously exposed to rabies. KamRAB is administered by a one-time injection, and the precise dosage is a function of the patient’s weight.