PHARMAESSENTIA ANNOUNCES POSITIVE TOPLINE PHASE 3 DATA FROM SURPASS-ET STUDY EVALUATING ROPEGINTERFERON ALFA-2B-NJFT (P1101) FOR ESSENTIAL THROMBOCYTHEMIA
In a significant breakthrough in the treatment of essential thrombocythemia (ET), PharmaEssentia Corporation, a global biopharmaceutical innovator based in Taiwan, has announced positive topline results from its SURPASS-ET study evaluating ropeginterferon alfa-2b-njft (P1101) for ET. The study demonstrated the efficacy and tolerability of P1101 in reducing platelet counts and alleviating symptoms associated with ET.
The SURPASS-ET Study
The SURPASS-ET study is a Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of P1101 in patients with ET. The study included 220 patients who were randomly assigned to receive either P1101 or placebo. The primary endpoint was the reduction in platelet counts from baseline to Week 24.
Key Findings
The results of the SURPASS-ET study showed that:
- Patients treated with P1101 had a significant reduction in platelet counts compared to those receiving placebo.
- P1101 was well-tolerated, with no significant differences in adverse events between treatment groups.
- The most common side effects were injection site reactions and fatigue.
Significance of the Results
The results of the SURPASS-ET study are significant because ET is a chronic, rare blood disorder that can significantly impact quality of life due to burdensome symptoms. Patients with ET face limited treatment options to manage their condition, particularly in reducing the risk of thrombosis and slowing disease progression.
P1101: A Promising New Treatment Option
Ropeginterferon alfa-2b-njft (P1101) is a novel interferon-based therapy that has shown promise in treating ET. P1101 works by targeting the bone marrow’s production of platelets, reducing their numbers and alleviating symptoms associated with ET.
PharmaEssentia’s Commitment to Innovation
PharmaEssentia is committed to delivering effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology. The company has a diversified pipeline of innovative therapies, including P1101, which is designed to address significant unmet medical needs.
Next Steps
The results of the SURPASS-ET study will be presented at an upcoming scientific conference. PharmaEssentia plans to submit regulatory applications for P1101 in ET and anticipates regulatory submission by the end of 2025.
About Essential Thrombocythemia (ET)
ET is a chronic, rare blood disorder that affects approximately 148,000 people in the United States. It is characterized by an overproduction of platelets, which can obstruct blood flow and cause a stroke, heart attack, or pulmonary embolism.
About BESREMi
BESREMi (ropeginterferon alfa-2b-njft) is a novel interferon-based therapy that has been approved in more than 40 countries for the treatment of polycythemia vera (PV). With its unique pegylation technology, BESREMi has a long duration of activity in the body and is designed to be administered once every two weeks.
About PharmaEssentia
PharmaEssentia Corporation is a global biopharmaceutical innovator headquartered in Taipei, Taiwan. The company was founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies. Today, PharmaEssentia has operations in the United States, Japan, China, and Korea, with a world-class biologics production facility in Taichung, Taiwan.
About the EXCEED-ET Study
PharmaEssentia is also conducting an ongoing Phase 2b clinical trial (EXCEED-ET) evaluating P1101 in ET patients in North America. The study aims to assess the efficacy and safety of P1101 in a larger patient population.
Contact Information
For more information about PharmaEssentia, please visit our website at www.pharmaessentia.com. You can also follow us on LinkedIn or X (formerly Twitter).
The results of the SURPASS-ET study are significant because they demonstrate the potential of P1101 as a new treatment option for patients with ET. The study’s findings provide valuable insights into the efficacy and tolerability of P1101 in reducing platelet counts and alleviating symptoms associated with ET.
Ropeginterferon alfa-2b-njft (P1101): A Promising New Treatment Option
P1101 is a novel interferon-based therapy that targets the bone marrow’s production of platelets, reducing their numbers and alleviating symptoms associated with ET. The study’s results demonstrate the potential of P1101 as a new treatment option for patients with ET.
PharmaEssentia’s Commitment to Innovation
PharmaEssentia is committed to delivering effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology. The company has a diversified pipeline of innovative therapies, including P1101, which is designed to address significant unmet medical needs.
About Essential Thrombocythemia (ET)
ET is a chronic, rare blood disorder that affects approximately 148,000 people in the United States. It is characterized by an overproduction of platelets, which can obstruct blood flow and cause a stroke, heart attack, or pulmonary embolism.
Next Steps
The results of the SURPASS-ET study will be presented at an upcoming scientific conference. PharmaEssentia plans to submit regulatory applications for P1101 in ET and anticipates regulatory submission by the end of 2025.
About BESREMi
BESREMi (ropeginterferon alfa-2b-njft) is a novel interferon-based therapy that has been approved in more than 40 countries for the treatment of polycythemia vera (PV). With its unique pegylation technology, BESREMi has a long duration of activity in the body and is designed to be administered once every two weeks.
About PharmaEssentia
PharmaEssentia Corporation is a global biopharmaceutical innovator headquartered in Taipei, Taiwan. The company was founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies. Today, PharmaEssentia has operations in the United States, Japan, China, and Korea, with a world-class biologics production facility in Taichung, Taiwan.
About the EXCEED-ET Study
PharmaEssentia is also conducting an ongoing Phase 2b clinical trial (EXCEED-ET) evaluating P1101 in ET patients in North America. The study aims to assess the efficacy and safety of P1101 in a larger patient population.
The results of the SURPASS-ET study are significant because they demonstrate the potential of P1101 as a new treatment option for patients with ET. The study’s findings provide valuable insights into the efficacy and tolerability of P1101 in reducing platelet counts and alleviating symptoms associated with ET.
Conclusion
In conclusion, the results of the SURPASS-ET study are significant because they demonstrate the potential of P1101 as a new treatment option for patients with ET. The study’s findings provide valuable insights into the efficacy and tolerability of P1101 in reducing platelet counts and alleviating symptoms associated with ET.
Contact Information
For more information about PharmaEssentia, please visit our website at www.pharmaessentia.com. You can also follow us on LinkedIn or X (formerly Twitter).
The results of the SURPASS-ET study are significant because they demonstrate the potential of P1101 as a new treatment option for patients with ET. The study’s findings provide valuable insights into the efficacy and tolerability of P1101 in reducing platelet counts and alleviating symptoms associated with ET.
About Essential Thrombocythemia (ET)
ET is a chronic, rare blood disorder that affects approximately 148,000 people in the United States. It is characterized by an overproduction of platelets, which can obstruct blood flow and cause a stroke, heart attack, or pulmonary embolism.
About BESREMi
BESREMi (ropeginterferon alfa-2b-njft) is a novel interferon-based therapy that has been approved in more than 40 countries for the treatment of polycythemia vera (PV). With its unique pegylation technology, BESREMi has a long duration of activity in the body and is designed to be administered once every two weeks.
About PharmaEssentia
PharmaEssentia Corporation is a global biopharmaceutical innovator headquartered in Taipei, Taiwan. The company was founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies. Today, PharmaEssentia has operations in the United States, Japan, China, and Korea, with a world-class biologics production facility in Taichung, Taiwan.
About the EXCEED-ET Study
PharmaEssentia is also conducting an ongoing Phase 2b clinical trial (EXCEED-ET) evaluating P1101 in ET patients in North America. The study aims to assess the efficacy and safety of P1101 in a larger patient population.
