PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology, oncology and immunology, today announced completion of enrollment for two clinical trials evaluating its ropeginterferon alfa-2b-njft (BESREMi®).
The Phase 2b EXCEED-ET trial (NCT05482971), which is evaluating the effectiveness and safety of ropeginterferon alfa-2b-njft in adult patients with essential thrombocythemia (ET), has exceeded the enrollment goal of 64 patients to include 91 patients. EXCEED-ET is evaluating people diagnosed with ET who are either treatment naïve or have received previous ET treatment with hydroxyurea or anagrelide but require a treatment change due to intolerance or because the previous treatment is no longer effective.
This trial is being conducted in the United States and Canada and will use the accelerated dosing schedule (250, 350, 500 mcg). This accelerated dosing schedule has been previously assessed in Asian clinical trials.
The Phase 3b ECLIPSE-PV trial (NCT05481151), assessing the effectiveness and safety of two dosing regimens of ropeginterferon alfa-2b-njft in adult patients with polycythemia vera (PV), has also exceeded the enrollment goal of 100 patients to include 111 patients. ECLIPSE-PV is evaluating two ropeginterferon alfa-2b-njft doses, including the accelerated dosing schedule (as described above) in comparison to the current recommended dosing regimen. The ECLIPSE-PV study is being performed in the United States and Canada.
“Myeloproliferative neoplasms, including ET and PV, are chronic blood diseases that can impact patients’ quality of life and lead to life-threatening complications, including the development of specific types of blood cancers, and PharmaEssentia is committed to developing new therapeutic solutions for these patients,” said Robert B. Geller, M.D., Head of Medical at PharmaEssentia USA. “We are thrilled with the pace at which we have enrolled patients, which we believe reflects a high level of interest in both the EXCEED-ET and ECLIPSE-PV trials. Our goal with each of these programs is to redefine the early treatment paradigm of myeloproliferative neoplasms.”
