Israel-based Kamada has completed patient enrolment in its US Phase II/III clinical trial of KamRAB as a post-exposure prophylaxis (PEP) treatment for rabies.
KamRAB is the company’s human rabies immune globulin, being marketed for this indication in six countries across the world.
Kamada and Kedrion have already entered into a strategic agreement for the clinical development and marketing of KamRAB in the US.
A total of 118 healthy subjects are enrolled in the prospective, randomised, double-blind, non-inferiority Phase II/III trial, which will evaluate the safety and effectiveness of KamRAB.
The trial will assess whether KamRAB interferes with the development of self-active antibodies.
Primary and secondary endpoints are pharmacokinetic (PK) parameters of anti-rabies IgG levels in serum at different time points, while safety and tolerability will also be evaluated in the trial.
Kamada co-founder and chief executive officer David Tsur said completion of recruitment for this Phase II/III clinical trial with KamRAB brings the company one step closer to expanding access to patients in the US, where there are around 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," Tsur said.
"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 US, 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."
Rabies is a preventable viral disease that causes acute inflammation of the brain in humans and other warm-blooded animals
The company said that KamRAB, which is administered by a one-time injection, is a prophylactic treatment against rabies infection that is given to patients after exposure to an animal suspected of being infected with rabies.
Image: Electron micrograph of the Rabies virus. Photo: courtesy of Patho.