Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Symphogen's Rozrolimupab (SYM001), a recombinant polyclonal antibody has demonstrated a favorable safety profile and induced a rapid increase in blood platelets in patients with Immune Thrombocytopenia Purpura (ITP).
Subscribe to our email newsletter
Rozrolimupab is a fully human recombinant anti-RhD monoclonal antibody (mAb) mixture, produced by a single-batch manufacturing strategy designed to capture the natural diversity of the human antibody response to RhD.
The open-label multi-center Phase 2 study clinical trial treated 61 patients with single doses from 75µg/kg to 300µg/kg, to evaluate the efficacy, safety, and tolerability of Rozrolimupab in adult, RhD positive, non splenectomized ITP patients.
The trial also showed that at 300µg/kg, 62% of patients responded at day 7, with the median time to response of 59 hours and the median duration response of 14 days.
In the study, the primary end point was defined as response at day 7 from Rozrolimupab administration as single infusions of 15-20 minutes duration.
University of Lodz, Poland professor Tadeusz Robak said the Phase 2 results support the fully human recombinant nature of Rozrolimupab, which makes it a promising, convenient replacement for older blood-derived immunoglobulins.