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By Randy Osborne, Staff Writer
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Taking what CEO Adam Grossman called “a different spin on
intravenous immunoglobulin [IVIG]” while “trying to provide a
product that’s very targeted, niche-focused, and is going to
provide an advantage to a subset” of the patient population,
Adma Biologics Inc. reported positive top-line phase III results
in primary immune deficiency diseases (PIDD) with lead
compound RI-002.
A plasma-derived, polyclonal, intravenous immune globulin,
RI-002 contains naturally occurring polyclonal antibodies such
as Streptococcus pneumoniae, Haemophilus influenzae type B,
cytomegalovirus, measles, tetanus, etc., as well as standardized,
high levels of antibodies to respiratory syncytial virus (RSV).
The compound met its primary endpoint in the 59-patient,
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PIDD patients.
PIDD comprises “about 150 different types of genetic defects
that affect certain aspects of the immune system,” Grossman
told BioWorld Today. In the U.S., about 250,000 patients have
one or more forms of PIDD, with half requiring monthly infusions
of IVIG to support their systems.
“There is a subset of the PIDD population that has combined
immune deficiency, meaning that they have both B and T cell
dysfunction,” Grossman said. “We’re providing a product that
has a unique antibody profile in that it has higher levels of
antibodies against all respiratory viruses over regular IVIG.
We think there’s a subset of about 8,000 to 20,000 patients
currently receiving IVIG who we believe clinicians would feel our
product would provide more protection at certain times of the
year,” such as winter.