Positive results in Phase III trial of RI 002 in PIDD-ADMA Biologics

ADMA Biologics announced positive results on the primary and secondary endpoint evaluations from its pivotal Phase III trial for RI 002 (intravenous immune globulin) in Primary Immune Deficiency Disease (PIDD) in a poster presentation at the American Academy of Allergy, Asthma and Immunology Annual Meeting. In this multi-site study of 59 patients diagnosed with PIDD, investigators reported on the secondary endpoints that included: a total of 93 days, or 1.66 days per patient per year lost from work or school due to infection; one hospitalization due to an infection of only five days duration in the entire study and IgG trough levels above those required by the FDA for IVIG products.

Additionally, there was a marked increase in all of the measured specific anti-pathogen antibodies in PK subjects (n=31), with the greatest increase, 5.3 fold, seen in the level of neutralizing antibody titers to RSV. The safety profile of RI-002 was comparable to that of other immunoglobulins. These encouraging secondary end point results follow the prior announcement that the trial achieved its primary endpoint with zero reported acute serious bacterial infections (SBI) in the course of the trial.