Evolve Biologics™ Reaches Major Milestones in Phase III Trial for Plasmacap™ IG (Intravenous Immunoglobulin), Including Dosing of First Pediatric Patient
Half of Required Infusions Now Successfully Administered in Adult Portion of Study
A Prospective, Open-Label, Multicenter Study of the Efficacy, Safety, Tolerability and Pharmacokinetics of PlasmaCap IG in Adults and Children with Primary Immune Deficiency Diseases
Mississauga, ON, Canada (May 4, 2018) – Evolve Biologics (“Evolve”), a division of Therapure Biopharma Inc. (“Therapure”) and an innovative developer of plasma-derived therapeutics, today announced 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.
The Phase III multicenter IVIG clinical trial has 13 study centers in the U.S. and Canada. Titled “A Prospective, Open-Label, Multicenter Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of Evolve PlasmaCap IG in Adults and Children with Primary Immune Deficiency Diseases,” the study will determine, based on historical control data, how PlasmaCap IG compares with other 10% IVIG products currently licensed in the U.S. and Canada for the treatment of patients with PIDD.
“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.”
Gabriel de Alba, Chairman of Therapure and Managing Director and Partner at The Catalyst Capital Group Inc., added, “We have made significant investments to create an innovative plasma-derived therapeutics business, built on our proprietary PlasmaCap EBA technology and led by an experienced, committed team. The PlasmaCap IG clinical study is proceeding well and is a major step toward achieving this vision.”
The study intends to recruit approximately 74 patients between ages two and 70 to achieve a total of 40 evaluable adult patients and 18 evaluable pediatric patients, who will be treated for one year. The study will assess the efficacy of PlasmaCap IG by determining whether the mean annual acute serious bacterial infection rate for the therapy is statistically significantly lower than one infection per patient per year. Evolve plans to submit a Biologics License Application (“BLA”) to the FDA based on the data generated from the adult portion of the trial.
“Primary immunodeficiency patients who need antibody supplementation often face a lifetime of immunoglobulin treatment,” 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. “These patients, as well as the clinicians who care for them, need treatment options to optimally manage their immunodeficiency. I am pleased to lead colleagues in the U.S. and Canada in this important Phase III clinical trial of Evolve’s innovative PlasmaCap IG in our continued quest to improve the outcomes and enhance the quality of life of immunodeficiency patients.”
About PlasmaCap EBA
PlasmaCap EBA is an innovative technology for efficient capture of plasma proteins at high yields and purities. PlasmaCap EBA 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 achieve significant capture yields for major plasma proteins of therapeutic value.
About Evolve Biologics™
Evolve Biologics, a division of Therapure Biopharma 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) which is in advanced stages of regulatory approval in Canada and the United States, and Albumin (human serum albumin). The Company is headquartered in Mississauga, Ontario, Canada. For more information, please visit www.evolvebiologics.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All opinions, forecasts, projections, future plans or other statements, other than statements of historical fact, are forward-looking statements. Forward-looking statements involve risks and uncertainties, including uncertainties regarding the matters described in this press release such as our ability to treat patients for one year in our IVIG trial and our ability to file a BLA with the FDA on the data generated from this IVIG trial as well as the impact it may have on Therapure Biopharma Inc. Forward-looking statements speak only as of the date of this press release, and Therapure Biopharma Inc. does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information or for any other reason, except as required by law.
Evolve Biologics™ is a trademark of Therapure Biopharma Inc.
Jeffrey Mathews / Dan Gagnier / Patrick Reynolds