Prometic Life Sciences Inc. (Prometic) announced positive clinical data from its pivotal IVIG phase 3 clinical trial, meeting its clinical primary and secondary endpoints in adult patients suffering from primary immunodeficiencies (PID). The clinical data presented at the Clinical immunology Society Annual Meeting in Toronto on April 27-28 2018 on Prometic’s IVIG demonstrated comparable safety and efficacy data to existing commercial IVIG products without any significant drug related safety issues.

The primary end point is the rate of clinically documented serious bacterial infections (SBIs), defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis or visceral abscess. The FDA Guidance for Industry on studies required to support marketing of IGIV states: “…a statistical demonstration of a serious infection rate per person-year less than 1.0 is adequate to provide substantial evidence of efficacy”. Since there were no SBIs observed during the study, Prometic IGIV 10% clearly meets this requirement.

Secondary endpoints including episodes of fever (=100.4°F), number of missed days, number of days of hospitalization due to infection, number of days on antibiotics, number of infections other than SBI, and trough IgG level were comparable between Prometic’s IGIV and commercial drugs. Only 4.94 days/subject/year were lost from work with Prometic IGIV 10%, which was significantly less than the rate observed while on commercial product.

The proportion of infusions for which at least one treatment-emergent adverse events (TAAE) that was reported was well within FDA guidance threshold across all time points within 72-hours post-infusion. Overall Prometic IGIV 10% appeared to be well tolerated and was not associated with any SBIs.

“The results with Prometic IGIV 10% met the FDA Guideline requirements for both safety and efficacy. This is the second plasma derived therapeutic clinical program to generate positive pivotal phase 3 results” said Pierre Laurin, President and CEO of Prometic. “This demonstrates the ability of our PPPS platform to generate positive data from both rare proteins targeting rare diseases as well as more commodity like proteins”.

Intravenous immunoglobulin is a preparation of antibodies purified from plasma donations from healthy individuals. It is indicated for the maintenance treatment of patients with primary immunodeficiencies (PID), including common variable immunodeficiency, X-linked agammaglobulinemia and severe combined immunodeficiency. It is also indicated for the treatment of immune thrombocytopenic purpura (ITP) and for many other autoimmune diseases, including Guillain-Barré syndrome, Kawasaki disease.

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%).

Prometic Life Sciences Inc. is a biopharmaceutical corporation with two drug discovery platforms focusing on unmet medical needs in the field of fibrosis and orphan diseases.