More than 80% of Required Infusions Now Successfully Administered in Adult Portion of Study
Recruitment and Enrollment of Patients in Pediatric Portion of Study Continues to Proceed On Plan
Abstracts on the Study and PlasmaCap EBA™ Technology Accepted for Presentation at Upcoming Immunoglobulin National Society (“IgNS”) Conference in Dallas, October 18 – 21, 2018
Mississauga, ON, Canada (September 25, 2018) – Evolve Biologics (“Evolve”), a division of Therapure Biopharma Inc. (“Therapure”) and an innovative developer of plasma-derived therapeutics, today provided an update on continued progress in its Phase III multicenter clinical trial of PlasmaCap™ IG (Intravenous Immunoglobulin or “IVIG”), an investigational IVIG replacement therapy being studied in both adult and pediatric patients with primary immune deficiency diseases (“PIDD”).
The study received approval to proceed from the U.S. Food and Drug Administration (“FDA”) and Health Canada in summer 2017. PlasmaCap IG has been developed utilizing Evolve’s innovative PlasmaCap EBA™ technology, which allows for more efficient capture of plasma proteins and offers the potential of higher yields and purities, compared to traditional manufacturing processes used in products currently available in the market. The study also further validates PlasmaCap EBA technology as the basis for additional critical, plasma-derived therapeutics in development.
“As both a clinical researcher and a physician caring for immunodeficiency patients, I’m very encouraged by the progress in enrolling the PlasmaCap IG Phase III trial,” 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. “With well over three quarters of the total adult doses administered to date, we continue to expect to complete the adult portion of the study in the first half of 2019. Just as important, every day we come closer to being able to offer patients additional treatment options to optimally manage their immunodeficiency.”
Recent developments in Evolve’s Phase III study of PlasmaCap IG include:
Abstracts on the study’s results and on the PlasmaCap EBA technology have been accepted for presentation at the upcoming conference of the influential Immunglobulin National Society (“IgNS”) in Dallas in October, where over 600 immunoglobulin physicians, pharmacists and nurses are expected to attend.
Evolve’s Chief Commercial Officer David Holliday added, “There is strong and growing interest in PlasmaCap IG, which indicates a clear need for reliable new sources of plasma-derived therapeutics, especially immunglobulins. We are excited to present our results at IgNS next month, and to continue discussions with the many dedicated immunoglobulin physicians, pharmacists and nurses attending the meeting.”
Gabriel de Alba, Chairman of Therapure and Managing Director and Partner at The Catalyst Capital Group Inc., concluded, “The continued progress of the PlasmaCap IG clinical study validates the substantial investment that Catalyst has made to develop the PlasmaCap EBA technology and to launch Evolve to meet the growing global demand for plasma-derived therapeutics, a market estimated to be in excess of $20 billion annually. We remain committed to this vision and to supporting the Evolve team as they realize it.”
The Phase III multicenter PlasmaCap IG 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.
The study is recruiting 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 is assessing 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 and Health Canada based on the data generated from the adult portion of the trial. IVIG PHASE III UPDATE DRAFT
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.
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, our expectation that the first adult patient dosed will finish the study within the next two weeks, our ability to continue to enroll pediatric patients into the study 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 / Lindsay Barber