ADMA's lead product meets primary endpoint in Phase III trial

US-based biopharmaceutical company ADMA Biologics (Nasdaq: ADMA) says that its lead product candidate RI-002 has demonstrated positive Phase III results and successfully achieved its primary endpoint.

The Phase III study enrolled 59 patients with diagnosed primary immune deficiency disease (PIDD) who received the investigational product, RI-002 for 12 months. Preliminary analysis indicates that treatment with RI-002 resulted in no serious bacterial infections (SBI) observed in study subjects during the trial. The company said this is well under the US Food and Drug Administration requirement of ≤1 SBI per patient-year and therefore the trial successfully achieved its primary endpoint.  Secondary endpoints include incidence of all infections (serious and non-serious), lost days of work or school, hospitalizations, emergency room visits and antibiotic use among others.

Unique antibody profile