Canada-based Prometic Life Sciences has reported positive interim results from an ongoing Phase III clinical trial of intravenous immunoglobulin (IVIG) in patients with primary immunodeficiencies (PID).
IVIG is made of antibodies that are purified from plasma donations obtained from healthy people.
The therapeutic is indicated as a maintenance treatment for PID disorders such as common variable immunodeficiency, X-linked agammaglobulinemia and severe combined immunodeficiency.
A review of six-month clinical data by the data safety monitoring board (DSMB) revealed no significant safety issues with the IVIG and its efficacy was found to be comparable to current commercial IVIG products.
The Phase III trial included 49 adult and ten paediatric subjects who were assessed for safety, levels of immunoglobulin (IgG), infection frequency, antibiotic use, missed days of school or work, and periods of hospitalisation due to severe infections.
Prometic Life Sciences president and CEO Pierre Laurin said: “These positive interim clinical results from our pivotal IVIG Phase III trial will enable us to complete the clinical portion of our new drug submission with Health Canada.
“We look forward to eventually commercialising our plasma-derived IVIG in Canada initially and contributing to Canada’s self-sufficiency with regards to plasma-derived therapeutics.”
The interim data is reported to have met Health Canada’s requirements for filing a new drug submission.
The requirements included a minimum of 20 evaluable patients with PID treated using the firm’s IVIG for at least six-months, and comparison data from a similar six-month period where patients were administered with comparable approved commercial IVIG products.