Samsung Bioepis Reports Positive Results for Phase 3 Study Soliris Biosimilar
July 12, 2022
Samsung Bioepis repoded SB12, its proposed biosimilar to Soliris (eculizumab), showed clinical equivalence in efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity between SB12 and reference eculizumab in patients with paroxysmal nocturnal hemoglobinuria.
The Phase 3 study results were presented as an e-poster at the 27th European Hematology Association 2022 (EHA2022) Hybrid Congress held in Vienna, Austria and virtually, from June 9 to 12, 2022.
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, chronic, life-threatening blood disorder caused by an acquired mutation, which leads to uncontrolled complement activation and the destruction of red blood cells through intravascular and extravascular hemolysis. According to a retrospective and a cross-sectional study of patients treated with C5 inhibitors, at least 72 percent had persistently low hemoglobin and at least 36 percent required one or more transfusions a year.
Soliris (eculizumab) is a humanized monoclonal antibody used in adults and children for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) and in adults for refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive and neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease2.
The study sought to determine clinical efficacy by evaluating the level of lactate dehydrogenase (LDH), safety, pharmacokinetics, pharmacodynamics, and immunogenicity of SB12 and reference eculizumab (ECU). The primary endpoints were LDH level at Week 26 and time-adjusted area of under the effect curve (AUEC) of LDH from Week 14 to Week 26 and from Week 40 to Week 52.
The results showed that 95 percent confidence interval of mean difference in LDH level at Week 26 between SB12 and reference eculizumab lied within the pre-defined equivalence margin. In addition, the 90 percent confidence interval of ratio of time-adjusted AUEC of LDH between SB12 and reference eculizumab lied within the pre-defined equivalence margin–indicating that the SB12 was bioequivalent to the reference eculizumab.
“We are fully aware that rare diseases, such as PNH pose many, but unique, challenges to patients and their families,” said Luke Oh, vice president and product evaluation team leader at Samsung Bioepis. “We will continue our journey to transform the way biologic therapies are brought to patients and enhance the lives of patients, including those with rare diseases, through our pioneering and innovative use of science and technology.”
Author: Rare Daily Staff
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