PharmaEssentia has announced the initiation of its ECLIPSE PV Phase IIIb clinical trial of ropeginterferon alfa-2b-njft (BESREMi) for the treatment of polycythemia vera (PV), a rare, chronic and life-threatening blood cancer.
The single-arm study will evaluate an accelerated dosing schedule for ropeginterferon alfa-2b-njft against the currently labelled dosing in 100 adults from US and Canada.
In this 48-week duration, subjects will receive starting dosage of 250mcg, 350mcg at week two, with a target optimal dose of 500mcg at week four.
The dosing will then remain fixed at the highest tolerated dose for the remaining treatment period.
The proportion of patients achieving a CHR, defined as haematocrit <45% for a minimum of three months since the last phlebotomy, platelets ≤ 400 x 109/L, leukocytes ≤10 x 109/L, at a treatment period of 24 weeks is the primary endpoint of the study.
The company plans to announce topline data by next year.
The study also includes a 28-day safety follow-up. People who respond positively to the treatment can take part in a long-term extension phase of the trial.
PharmaEssentia Clinical Development and Medical Affairs US head Raymond Urbanski said: “Our goal with this study is to deliver evidence on the potentially enhanced benefits of treating patients with BESREMi through this accelerated dosing schedule and to bring additional confidence to clinicians and patients in the utility of the treatment to manage this chronic cancer.
“We believe this study will deliver further insight into the potential of BESREMi to meet the needs of PV patients.”