Endpoints Hit in Phase 3 Immunodeficiencies Trial

At the Clinical immunology Society Annual Meeting in Toronto on April 27-28, Prometic presented data from its pivotal Intravenous Immunoglobin (IVIG) Phase 3 clinical trial.

The results revealed that IVID met primary and secondary endpoints in adult patients suffering from primary immunodeficiencies (PID), including Guillain-Barré syndrome, by demonstrating comparable safety and efficacy data to existing IVIG products without any significant drug related safety issues.

The rate of clinically documented serious bacterial infections (SBIs) served as the primary endpoint, and SBIs were defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis or visceral abscess. According to the FDA Guidance for Industry on studies required to support marketing of IGIV: "…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 observed SBIs throughout the study, Prometic IGIV 10% meets the requirement.

"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 in a press release. "This demonstrates the ability of our PPPSTM platform to generate positive data from both rare proteins targeting rare diseases as well as more commodity like proteins".

Between Prometic's IGIV and commercial drugs, 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.

Only 4.94 days per subject per 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 1 treatment-emergent adverse events (TAAE) that was reported was within FDA guidance threshold across all time points within 72-hours post-infusion. Overall, Prometic IGIV 10% was not associated with any SBIs and appeared to be well tolerated.

A total of 145 TAAEs (0.3/infusion) occurred in 64.0% of subjects (n=32) with 20% infusions (n=92) associated with a TAAE. Most infusions (97.0%) were completed without a rate reduction. Most TAAEs were mild or moderate in severity, with 6 severe TAAEs (0.01/infusion) occurring in 6% of subjects (n=3). The most frequent TAAEs were headache (20.0% subjects or 0.06/infusion) and fatigue (14.0% subjects or 0.02/infusion).

The poster presented at the Clinical Immunology Society Annual Meeting in Toronto can be found on Prometic's corporate website.

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