Kedrion Biopharma announces that enrollment is complete in the CARES10 (Clinical Assessment of phaRmacokinetics, Efficacy, Safety of a 10% Ig) clinical study.
CARES10 is a United States-based open-label, prospective, multi-center phase 3 clinical study to assess efficacy, safety and pharmacokinetics of a 10 percent intravenous immunoglobulin in the treatment of adult patients with primary immunodeficiency diseases (PI). Clinical lots for this trial are currently being produced in our Gödöllő, Hungary manufacturing site.
The last patient enrolled in CARES10 is being treated at one of the 12 sites in the study. The study is scheduled to be completed by mid-2021. A subsequent goal will be to submit a biologics license application (BLA) to the U.S. Food and Drug Administration.
"Completing enrollment in the CARES10 study is a very important milestone for Kedrion Biopharma," said Paolo Marcucci, Kedrion Biopharma chairman and chief executive officer. "With this achievement, our company has taken yet another step toward bringing patients diagnosed with primary immunodeficiency another treatment option for this rare and serious condition. We are pleased and excited to be on this journey."
Kedrion Biopharma completed enrollment in CARES10 approximately a month earlier than planned. With this clinical study, the company expands its long-term strategic focus to include entry into scientific research and development of plasma-derived therapies.