ADMA Biologics’ IVIG Product (RI-002) Receives Positive Phase III Results
- By BSTQ Staff
ADMA Biologics has received positive results on the primary and secondary endpoint evaluations from the Phase III trial for its intravenous immune globulin (IVIG) product RI-002 to treat primary immunodeficiency disease (PI). The multi-site study treated 59 PI patients with RI-002, which resulted in a total of 93 days (1.66 days per patient per year) lost from work or school due to infection; only one hospitalization due to an infection of only five days; and IgG trough levels above those required by the U.S. Food and Drug Administration (FDA) for IVIG products. In addition, there was a marked increase in all of the measured specific anti-pathogen antibodies in subjects with the greatest increase (5.3-fold) seen in the level of neutralizing antibody titers to respiratory synctial virus (RSV). The safety profile was comparable to that of other IG products.
“These Phase III results suggest that RI-002 and its unique antibody profile containing standardized high levels of anti-RSV neutralizing antibodies may demonstrate an improvement in certain clinical outcomes,” said James Mond, MD, PhD, ADMA Biologics’ chief medical and scientific officer. “We believe that the data from the primary and secondary outcomes analyses will enable ADMA to differentiate RI-002 from other IVIG products and offer clinicians and patients a promising alternative to current therapies for the immune deficient population.” ADMA is currently assembling its Biologics License Application for planned submission to FDA during the first half of 2015.
