PharmaEssentia Corporation announced that the company received positive opinions from the Data and Safety Monitoring Board (DSMB) of the phase III clinical trial of Ropeginterferon alfa-2b (P1101) for the treatment of essential thrombocythemia (ET). Based on the current data, DSMB confirmed the safety of the study and recommended continuing the study according to the protocol. Upcoming development plan is to continue the phase III clinical trial of Ropeginterferon alfa-2b for the treatment of essential thrombocythemia.

Estimated date of completion is the phase III clinical trial recruitment is expected to be completed by the end of 2022. The timeline will be adjusted according to the actual progress of the clinical trial. The phase III clinical trial of Ropeginterferon alfa-2b for essential thrombocythemia is expected to enroll 160 subjects, with more than 70% subjects enrolled so far.

Ropeginterferon alfa-2b has been approved to treat adult patients with PV in the European Union, Taiwan, Switzerland, Israel, South Korea, and the United States.