MISSISSAUGA, Ontario--(BUSINESS WIRE)--Evolve Biologics Inc. (“Evolve”), an innovative plasma-derived therapeutics company, today announced that it has successfully completed its adult and pediatric Phase III clinical trial of PlasmaCap IG (Intravenous Immunoglobulin or “IVIG”), conducted at 12 study centers across the U.S. and Canada. PlasmaCap IG is an investigational IVIG replacement therapy for adult and pediatric patients with primary immune deficiency disease (“PIDD”).
The trial assessed the efficacy of PlasmaCap IG by determining whether the mean annual acute serious bacterial infection rate for the therapy was statistically significantly lower than one infection per patient per year. PlasmaCap IG utilizes Evolve’s proprietary PlasmaCap EBA technology, which processes plasma more efficiently and reliably than currently available technologies, enabling Evolve to produce more grams of high-quality immunoglobulin (IG) from each liter of plasma. Upon completion of its first commercial facility, which is already in early development, Evolve plans to submit a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) and Health Canada, which will include data generated from both the adult and pediatric portions of the trial.
“This is a very important milestone for Evolve, bringing us another step closer to our mission to revolutionize the global market for plasma-derived therapeutics. PlasmaCap IG is our first product to complete a Phase III clinical trial and targets a large, critical and underserved global market,” said Jim Caggiano, Chief Executive Officer at Evolve. “The successful completion of both adult and pediatric clinical portions of the trial further validates Evolve’s unique PlasmaCap EBA technology. We are eager to bring PlasmaCap IG to market while we continue to develop new plasma-derived therapeutic options for patients with rare diseases.”
Gabriel de Alba, Chairman of Evolve and Managing Director and Partner at The Catalyst Capital Group Inc., added, “Over the past years, with hard work and significant investment, we have built a world-class biologics business. In addition to our experienced leadership team and proprietary PlasmaCap EBA technology, the successful completion of Phase III trials for IVIG indicates Evolve’s tremendous potential to bring new sources of plasma-derived therapeutics business to the global market, for the benefit of patients and medical professionals worldwide.”
Key findings from the Phase III trial of PlasmaCap IG include:
- A total of 839 infusions were administered to 48 adults age 20-70 years (median 51.0 years) and 15 children age 2-16 years (median 9.0 years).
- There were no acute serious bacterial infections, meeting the primary study endpoint of <1 acute serious bacterial infection per patient-year.
- The trial also met all of its secondary efficacy and safety endpoints including the following:
− Quality of life measures comprising days absent from work or school due to an infection, hospitalization due to infection and febrile days >38.5°C were all low.
− More than 98% of the infusions were completed without discontinuation or interruption, and 97% of all treatment-related adverse events reported were mild or moderate; the most common treatment-related adverse events were headache, fatigue and nausea.
− No subject experienced a treatment-related serious adverse event, hemolysis, thromboembolism or renal failure.
Evolve also announced that the Clinical Immunology Society (CIS) has accepted the abstract “Efficacy and Safety of PlasmaCap IG, A New 10% Intravenous Immunoglobulin Manufactured Using an Innovative Chromatography Process, in Adults and Children with Primary Immunodeficiency Disorders” for poster presentation at the CIS Annual Meeting in April 2021. The poster will provide an overview of the key methods, results, and conclusions from the PlasmaCap IG Phase III trial.
"With the completed PlasmaCap IG trial in both adults and children meeting the primary and secondary endpoints, I look forward to the addition of this important new entrant into the immunoglobulin marketplace," said Richard L. Wasserman, M.D., Ph.D., Medical Director of Pediatric Allergy and Immunology at Medical City Children’s Hospital (Dallas, Texas) and lead investigator of the study. "Primary immunodeficiency patients, who depend on the availability of life-saving immunoglobulin replacement therapy, will be well served by the addition of this high-quality immunoglobulin product, which will increase their treatment options. Augmenting the long-term supply of immunoglobulin is critically important, as seen during the pandemic when there have been challenges to maintaining adequate product to meet patient's needs."
About PlasmaCap EBA®
PlasmaCap EBA is an innovative technology for efficient capture of plasma proteins at high yields and purities from human blood plasma. The technology uses proprietary affinity adsorbents in expanded bed adsorption (EBA) chromatography to capture plasma proteins directly from plasma or fractionated plasma materials without the use of precipitating solvents such as ethanol. Through substantial development efforts, PlasmaCap EBA® has been able to demonstrate significant capture yields for major therapeutic plasma proteins.
About Evolve Biologics® Inc.
Evolve Biologics Inc. is a leader in the development and commercialization of plasma-derived therapeutics, using its proprietary PlasmaCap EBA purification technology to more efficiently and effectively meet growing global patient demand for these life-saving products. The Company is currently in the process of commercializing an exciting and innovative portfolio of product candidates, including IVIG (intravenous immunoglobulin) and Albumin (human serum albumin), both of which are in advanced stages of regulatory approval in the US (FDA) and Canada (Health Canada). The Company is headquartered in Mississauga, Ontario, Canada. For more information, please visit: www.evolvebiologics.com.
Evolve Biologics® and PlasmaCap EBA® are registered trademarks of Evolve Biologics Inc.