PharmaEssentia announced on June 25 that enrollment has been completed for two clinical trials of its new drug Ropeg in the United States and Canada - EXCEED-ET and ECLIPSE-PV. The final enrollment numbers reached 142% and 111% of their respective targets, indicating high interest from clinical research institutions in Ropeg's significant efficacy and safety profile.
EXCEED-ET is a phase 2b, single-arm clinical trial without a control group, designed to evaluate the efficacy and safety of Ropeg in adult patients with essential thrombocythemia (ET). The final enrollment reached 91 patients, surpassing the original target of 64 patients by 142%. EXCEED-ET enrolled patients who were either treatment-naive ET patients or those who had previously received Hydroxyurea or Anagrelide but required a change in treatment due to intolerance of side effects or inefficacy.
EXCEED-ET employs Ropeg's rapid dose escalation regimen (250-350-500 micrograms), which was previously evaluated in Ropeg's clinical trials in Asia. Clinical results showed that Ropeg's rapid dose escalation regimen was highly effective and well-tolerated in patients with polycythemia vera (PV), with research papers repeatedly published in international journals.
ECLIPSE-PV is a phase 3b clinical trial primarily evaluating the efficacy and safety of two Ropeg dosing regimens (the aforementioned rapid dose escalation regimen and the current label-recommended dosing regimen) in adult PV patients. The final enrollment reached 111 patients, exceeding the original target of 100 patients by 111%.
Robert B. Geller, the newly appointed Medical Affairs Director of PharmaEssentia's U.S. subsidiary, stated that the enrollment for Ropeg's two clinical trials was completed with "hockey stick growth," surpassing the original target enrollment numbers. This reflects the medical community's high interest in the EXCEED-ET and ECLIPSE-PV clinical trials, hoping to redefine the early treatment model for MPNs. The goal is to allow patients to use Ropeg early and long-term after being diagnosed with PV, further strengthening the current U.S. NCCN guidelines' recommendations for Ropeg.
The global multi-center phase III clinical trial of Ropeg for ET (SURPASS-ET) completed enrollment on October 25 last year. It is expected that the primary efficacy endpoint data collection will be completed in the first quarter of 2025, followed by applications for drug approvals in various countries. Approval is anticipated between late 2025 and early 2026. Pre-marketing preparations are currently underway, with Ropeg poised to become the second engine accelerating PharmaEssentia's operational growth.
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