COPENHAGEN, Denmark – Symphogen today 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.”
About Rozrolimupab (SYM001)
Rozrolimupab is a fully human recombinant anti-RhD monoclonal antibody (mAb) mixture, comprised of 25 mAbs binding to RhD. Rozrolimupab is produced by a single-batch manufacturing strategy designed to capture the natural diversity of the human antibody response to RhD as a modern counterpart to the plasma-derived anti-RhD immunoglobulins currently used in the treatment of ITP.
Symphogen develops antibody therapeutics (mixtures of monoclonal antibodies) to help people with serious diseases and significant unmet medical needs. With its proprietary, unique Symplex™ discovery, SymSelect™ lead selection and Sympress™ manufacturing platforms, the company captures the diversity and specificity of the natural immune response in rationally designed recombinant antibody compositions. Symphogen is maturing a diversified pipeline of internal and partnered products across multiple indications including cancer, autoimmune and infectious disease. Symphogen is a private biopharmaceutical company headquartered in Copenhagen, Denmark. For more information, please visit www.symphogen.com.