PharmaEssentia Corporation announced the initiation of SURPASS ET, a Phase 3 pivotal clinical trial of its investigational ropeginterferon alfa-2b (P1101), a novel mono-pegylated proline interferon under evaluation for the treatment of the essential thrombocythemia (ET), one form of myeloproliferative neoplasms (MPNs). Myeloproliferative neoplasms (MPNs) are caused by specific genetic mutations that lead to overproduction of blood components, including white or red blood cells. ET is one of the group of MPNs, caused by an overproduction of platelets. The disease, which is estimated to affect up to 57 per 100,000 people in the U.S., initially presents with symptoms such as fatigue, anemia and splenomegaly. Over time, ET is known to evolve into myelofibrotic phases with increasingly debilitating symptoms and greater mortality. The multi-site, open-label, randomized, active-controlled study will compare the efficacy, safety, and tolerability and pharmacokinetics of P1101 as second line therapy for ET as compared with anagrelide, a commonly used oral platelet-reduction therapy. The study aims to enroll approximately 160 patients, who will be randomized to receive either P1101 subcutaneously every two weeks or anagrelide at a standard dose. Eligible patients will include high-risk ET patients, those who are resistant to or intolerant of hydroxyurea and who have not received prior therapy with interferon. The study builds on the company’s recent momentum to deliver new solutions in MPNs. The company filed a Biological License Application (BLA) with the U.S. Food and Drug Administration (FDA) for Ropeginterferon alfa-2b. The company is seeking approval for its first product indication in polycythemia vera (PV) in the US, and expects an agency decision early in 2021.