Specialty immune globulin company ADMA Biologics has dosed the first patient in a pivotal Phase III clinical study of RI-002, for the treatment of patients with primary immune deficiency diseases (PIDD).
Derived from human plasma, RI-002 is a polyclonal intravenous immune globulin containing naturally occurring polyclonal antibodies (streptococcus pneumoniae, influenza B, CMV, measles, tetanus etc.) as well as high levels of antibodies targeted at respiratory syncytial virus or RSV.
The study will enrol 60 to 70 patients from investigative centres across the US.
The study will evaluate the efficacy and safety of RI-002 in patients for a 12-month treatment period, followed by up to 90 days of safety monitoring and follow-up.
ADMA Biologics president and chief executive officer Adam Grossman said RI-002 will offer PIDD patients additional treatment options, and provide clinicians, who see all types of immune deficient patients, with greater flexibility.
"We are excited to be working with leaders in the PIDD community to evaluate the safety and efficacy of RI-002," Grossman said.
University of Texas Southwestern Medical School pediatrics clinical professor and study lead principal investigator Dr Richard Wasserman said; "Having access to a specialty, high titer immune globulin product such as RI-002, indicated for use in the PIDD population would be a welcome addition to currently available therapies."