Positive Results for Phase II Clinical Trial for ITP Patients

Symphogen has presented final Phase II data demonstrating that its recombinant polyclonal antibody drug candidate rozrolimupab exhibited a favorable safety profile and induced a rapid increase in blood platelets in patients with immune thrombocytopenia purpura (ITP). The Phase II study was an open-label, multicenter clinical trial evaluating the efficacy, safety and tolerability of rozrolimupab (SYM001) in adult RhD positive, nonsplenectomized ITP patients. Results demonstrated that at 300 ug/kg, eight of 13 (62 percent) patients responded at day seven. The median time to respond was 59 hours, and the median duration of response was 14 days. The most common adverse events, mostly mild to moderate, were headache (18 percent), pyrexia (13 percent), chills (8 percent) and fatigue (8 percent). Four serious adverse events considered related to the drug were reported: decreased hemoglobin, extravascular hemolysis/dizziness and two cases of transient rise in D-dimer values without clinical symptoms.