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Swedish Orphan Biovitrum AB announced positive results from the XTEND-Kids phase 3 study, demonstrating the safety and efficacy of efanesoctocog alfa in children under 12 with severe hemophilia A. The primary endpoint was successfully met, with no factor VIII inhibitors detected in the 74 participants. Notably, the median annualized bleeding rate was reported at 0.00, indicating effective bleed protection. The study's completion paves the way for regulatory submission in the EU, building on prior successes of the XTEND-1 trial. Efanesoctocog alfa, recently approved in the US, is positioned to potentially redefine the standard of care for hemophilia A.
On October 9, 2020, Swedish Orphan Biovitrum AB (Sobi) announced topline results from a phase 3 study of avatrombopag for chemotherapy-induced thrombocytopenia (CIT). Despite increasing platelet counts compared to placebo, the study did not meet its primary endpoint of preventing platelet transfusions, chemotherapy dose reductions, or delays. In the intent-to-treat population, responder rates were 69.5% for avatrombopag versus 72.5% for placebo (p=0.72). Sobi remains optimistic about avatrombopag's potential benefits and is continuing its focus on other indications, with peak sales estimates unchanged.
On October 22, 2020, at 08:00 CET, Swedish Orphan Biovitrum AB (Sobi™) will release its Q3 2020 report. A teleconference, hosted by CEO Guido Oelkers, will follow at 13:00 CEST for investors and media. The event will be accessible live and thereafter on Sobi's website. Sobi focuses on rare diseases, employing around 1,400 staff across multiple regions. In 2019, Sobi reported a revenue of SEK 14.2 billion. Further details can be found on Sobi’s website.
S Swedish Orphan Biovitrum AB and Selecta Biosciences announced topline results from the phase 2 COMPARE study of SEL-212 for chronic refractory gout. Although SEL-212 demonstrated a higher response rate compared to pegloticase in some endpoints, it did not achieve statistical superiority on the primary endpoint. The study showed a statistically significant greater reduction in serum uric acid levels with SEL-212. Both treatments were well-tolerated, with no deaths reported. The findings suggest SEL-212 could address unmet medical needs and advance to phase 3 trials.
