Prometic Life Sciences has announced positive interim six-month clinical data from its ongoing pivotal IVIG phase 3 clinical trial in patients suffering from primary immunodeficiencies (PID) following review of the data by the Data Safety Monitoring Board (DSMB), which confirmed no significant safety issues and that efficacy appeared to be comparable to existing commercial IVIG products.

The current data meets Health Canada’s requirements for a New Drug Submission (NDS) filing with at least 20 evaluable PID patients treated with Prometic’s IVIG for a minimum six-month period together with comparison data from a similar six-month period during which patients received comparable approved commercial IVIG products. Forty-nine adult and 10 pediatric patients have completed at least six months of treatment with Prometic’s IVIG in the current trial. Comparisons with the approved products include safety, Immunoglobulin (IgG) levels, frequency of infections, use of antibiotics, periods of hospitalization due to severe infections and missed days of school or work.

“These positive interim clinical results from our pivotal IVIG phase 3 trial will enable us to complete the clinical portion of our New Drug Submission with Health Canada”, said Pierre Laurin, president and chief executive officer of Prometic. “We look forward to eventually commercializing our plasma-derived IVIG in Canada initially and contributing to Canada’s self-sufficiency with regards to plasma-derived therapeutics”.

Commenting on the interim IVIG data, Bill Bees, Vice President of Plasma Technologies at Prometic Plasma Resources Inc., stated: “In addition to confirming our ability to produce commercial quality IVIG, the positive clinical results confirm Prometic’s hyperimmune product platform. By actively pursuing the manufacture of specialty IgGs using our proprietary process and leveraging our speciality plasma collection center, we continue to play a leading role in targeting and addressing unmet medical needs requiring plasma-derived therapeutics”.

According to recent market data, Canada is ranked as the second country in the world after the United States for the average consumption of IVIG (measured in kilograms per million people), with sales exceeding $600 million in 2016. The global IVIG market CAGR is expected to reach 5-6% between 2016 and 2025 with Canada having one of the lowest IVIG self-sufficiency ratios (i.e. less than 20%).