On October 21, 2021 PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported plans to present new updates on its pipeline during the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 11-14, 2021 (Press release, PharmaEssentia, OCT 21, 2021, View Source [SID1234591710]).
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"Since we initiated the study in the U.S. earlier this year, we have heard from clinicians outside the U.S. who are eager to consider a new investigational option to support their ET patients. We are pleased to partner with these renowned MPN specialists to participate in this important study."
During the meeting, the company will provide an update on 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 essential thrombocythemia (ET). PharmaEssentia continues to enroll participants in the trial at sites throughout the United States and Asia, and has now expanded with new sites in Canada.
"People diagnosed with a myeloproliferative neoplasm (MPN), and particularly those with ET, have limited therapeutic options that can help them manage the progressive effects of the disease, so through this study, we will evaluate whether our mono-pegylated interferon could represent a useful alternative to currently available options," said Raymond Urbanski, M.D., Ph.D., U.S. Head of Clinical Development and Medical Affairs. "Since we initiated the study in the U.S. earlier this year, we have heard from clinicians outside the U.S. who are eager to consider a new investigational option to support their ET patients. We are pleased to partner with these renowned MPN specialists to participate in this important study."
The SURPASS ET open-label, randomized, active-controlled study is comparing 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 include high-risk ET patients, those who are resistant to or intolerant of hydroxyurea and who have not received prior therapy with interferon.
The primary efficacy endpoint for the study employs the modified European Leukemia Net (ELN) criteria. Secondary efficacy endpoints include time to and durability of response, response rates based on hematologic parameters and symptomatic improvements. Changes in CALR, MPL, and JAK2 allelic burden over time is also being investigated. Topline data are expected by late 2022. More details on the study design and sites are available at www.clinicaltrials.gov (NCT04285086) or at www.SURPASSET.com.
PharmaEssentia continues to build momentum with its pipeline to deliver new solutions in MPNs. The company is seeking approval for its first indication in polycythemia vera (PV) in the U.S. and expects a decision by the U.S. Food and Drug Administration (FDA) in November 2021.
About Ropeginterferon alfa-2b
Ropeginterferon alfa-2b is a long-acting, mono-pegylated proline interferon aimed to be administered once every two weeks or longer. Ropeginterferon alfa-2b has Orphan Drug designation for treatment of polycythemia vera (PV) in the United States. Marketed as Besremi in Europe, the product was approved by the European Medicines Agency (EMA) in 2019. Ropeginterferon alfa-2b was discovered and is manufactured by PharmaEssentia in its Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018.
About Essential Thrombocythemia
Essential thrombocythemia (ET) is a myeloproliferative neoplasm (MPN) characterized by an overproduction of platelets in the blood that results from a genetic mutation; data indicates a JAK2 gene mutation is present in approximately half of diagnosed patients. ET is estimated to affect up to 57 per 100,000 people in the U.S. The disease is most commonly diagnosed through routine blood work, and is most common in people over the age of 50, with women 1.5 more times more likely to be diagnosed than men. As a chronic, progressive disease, ET requires regular monitoring and appropriate treatment. Over time, the disease may progress into more deadly conditions such as myelofibrosis or acute leukemia.1,2