Symphogen Presents Positive Rozrolimupab (SYM001) Phase 2 Trial Results in ITP at ASH
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Symphogen has presented final Phase 2 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 trial demonstrated that at 300µg/kg, the best dose, 8 of 13 (62%) of patients responded at day 7.
Median time to response was 59 hours (approximately 2.5 days) and the median duration of response was 14 days.
The Phase 2 study was an open-label, multi-center clinical trial evaluating the efficacy, safety, and tolerability of rozrolimupab (SYM001) in adult, RhD positive, non-splenectomized ITP patients.
At the 53rd Annual Meeting of the American Society of Hematology (ASH) (http://www.hematology.org/Meetings/Annual-Meeting/) in San Diego CA in an oral session: “Disorders of Platelet Number or Function,” Professor Tadeusz Robak of the University of Lodz, Poland, (the lead investigator on the study), presented a detailed analysis of the study’s findings in a talk entitled, “Final Results From a Phase II Trial with the First-in-Class Recombinant Polyclonal Antibody Product Rozrolimupab in Primary Immune Thrombocytopenia (ITP)”.
The primary end point of the study was defined as response at day 7 from rozrolimupab administration. In the study, 61 patients were treated with single doses from 75µg/kg to 300µg/kg.
Rozrolimupab was administered as single infusions of 15-20 minutes duration. Response was defined as platelet counts of >30 x 10^9/L and an increase of >20 x 10^9/L from baseline.
The most common adverse events, mostly mild or moderate, were headache (18%), pyrexia (13%), chills (8%), and fatigue (8%). Four serious adverse events considered related to study drug were reported: decreased hemoglobin, extravascular hemolysis/dizziness and two cases of transient rise in D-dimer values without clinical symptoms.
According to Dr. Robak “The Phase 2 results suggest a preliminary efficacy profile quite similar to that seen with plasma derived immunoglobulin products. The fully human recombinant nature of rozrolimupab makes it a promising, convenient replacement for older blood-derived immunoglobulins which while effective, carry the potential risk of disease transmission and have often been in short supply.”
