Evolve Biologics, a division of Therapure Biopharma Inc., announced on 5/4/18 that it has dosed the first pediatric patient in its Phase III multicenter clinical trial of PlasmaCap IG (Intravenous Immunoglobulin or “IVIG”), in addition to having administered half of the infusions required for the adult portion of the study, which completed enrollment in February 2018. The study received approval to proceed from the U.S. Food and Drug Administration (“FDA”) and Health Canada last summer.
PlasmaCap IG is an investigational IVIG replacement therapy being studied in both adult and pediatric patients with primary immune deficiency diseases (“PIDD”). PlasmaCap IG has been developed utilizing Evolve’s innovative PlasmaCap EBA technology, which allows for the efficient capture of plasma proteins and offers the potential of higher yields and purities. The existing plasma protein products available in the market and derived from human plasma are still primarily produced using the traditional Cohn manufacturing process, originally developed in the 1940s.
“We are pleased to announce we have now dosed the first pediatric patient in this important study of PlasmaCap IG. In addition, we have successfully reached the mid-point for the adult portion of our study, having administered half of the total infusions,” said Blaine Forshage, Evolve’s CEO. “These events mark important progress in this study. PlasmaCap IG is the first product in our portfolio to be studied in a clinical setting and demonstrates our commitment to bringing modern and innovative technologies to the growing global market for plasma-derived therapeutics, as well as developing new therapeutic options for both adult and pediatric patients with a number of rare chronic diseases, including PIDD.”
PIDD are a group of more than 130 distinct disorders caused by genetic defects of the immune system. Most of these disorders are caused by single gene defects, but the variable penetrance of these mutations results in heterogeneous phenotypes which leads to delays in diagnosis. Prevalence of PIDD has been estimated between approximately 50 and 80 per 100,000.
