PharmaEssentia Concludes Patient Enrollment For Phase 2b EXCEED-ET

PharmaEssentia USA Corporation, a worldwide biopharmaceutical trailblazer situated in Taiwan utilizing profound mastery and demonstrated scientific principles to convey new biologics in hematology, oncology and immunology, declared completion of enlistment for two clinical preliminaries assessing its ropeginterferon alfa-2b-njft (BESREMi®).

The number of participants in the Phase 2b EXCEED-ET trial (NCT05482971), which is assessing the safety and efficacy of ropeginterferon alfa-2b-njft in adult patients with essential thrombocythemia (ET), has increased to 91 from the initial goal of 64. EXCEED-ET is evaluating individuals who have been diagnosed with ET and are either treatment nave or have previously received hydroxyurea or anagrelide treatment for ET but require a treatment change due to intolerance or the ineffectiveness of the previous treatment. The accelerated dosing schedule (250, 350, and 500 mcg) will be used in this study, which is taking place in the United States and Canada. Asian clinical trials have previously evaluated this accelerated dosing schedule.

The enrollment goal for the Phase 3b ECLIPSE-PV trial (NCT05481151), which is evaluating the safety and efficacy of two dosing regimens of ropeginterferon alfa-2b-njft in adult patients with polycythemia vera (PV), has also been met, with 111 patients participating.  ECLIPSE-PV is assessing two ropeginterferon alfa-2b-njft portions, including the advanced dosing plan in contrast with the ongoing suggested dosing routine. In the United States and Canada, the ECLIPSE-PV study is being carried out.