• Phase 1 study demonstrated pharmacokinetics (PK) equivalence and comparable pharmacodynamic (PD), safety, immunogenicity profiles between SB12 and reference eculizumab
 

INCHEON, Korea – December 11, 2021 – Samsung Bioepis Co., Ltd. today announced that SB12, a proposed biosimilar to Soliris^®i  (eculizumab), met all the endpoints in the Phase 1 study that evaluated PK, PD, safety, tolerability, and immunogenicity profiles between SB12 and reference eculizumab in healthy volunteers. The Phase 1 study results were presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition held from December 11 to 14, 2021, at Georgia World Congress Center, Atlanta, GA.
 
Soliris^® is a humanized monoclonal antibody that binds to the human C5 complement protein and is currently used for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uremic syndrome (aHUS), refractory generalized Myasthenia Gravis (gMG) and Neuromyelitis Optica Spectrum Disorder (NMOSD)ⁱⁱ. 
 

In a double-blind, three-arm, parallel group study in 240 healthy volunteers, participants were randomized in a ratio of 1:1:1 to receive a single 300 mg dose of either SB12, European Union (EU)-sourced eculizumab, or United States (US)-sourced eculizumab via intravenous (IV) infusion for 35 minutes. The primary objective of this study was to demonstrate PK similarity, as assessed by area under the concentration-time curve from time zero to infinity (AUCinf). Secondary PK endpoints included area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) and maximum observed concentration (Cmax).
 

For all comparisons, the 90% Confidence Intervals (CI) of the geometric Least-Squares Mean (LSMean) ratios of the primary (AUCinf) and secondary PK endpoints (Cmax and AUClast) were fully contained within the pre-defined bioequivalence margin of 80.00-125.00%, indicating that SB12 was bioequivalent to both EU- and US-sourced eculizumab.
 

Safety profiles including immunogenicity were also comparable between the SB12, EU-sourced eculizumab, and US-sourced eculizumab treatment groups. There was no death or discontinuation due to treatment-emergent adverse events (TEAEs).
 
“We are excited to share the Phase 1 clinical results of our first hematology biosimilar with the medical society. Biosimilars have much potential to bring benefits to patients suffering from PNH because patients with rare diseases often have limited access to treatments due to high cost of medicines,” said Dong-hoon Shin, Vice President and Medical & Lifecycle Team Leader at Samsung Bioepis. He continued, “we will continue to advance our clinical development efforts to demonstrate biosimilarity and quality of our eculizumab biosimilar through Phase 3 study, and advance our innovative development platform to bring affordable, additional treatment options for patients who don’t have access to medicines.”
 
Details of the SB12 abstract are as follows:
• Abstract Title: A Randomized, Double-Blind, Single-Dose Phase 1 Comparative Pharmacokinetic Study Comparing SB12 (Eculizumab Biosimilar)
   with Reference Eculizumab in Healthy Volunteers
• Abstract number: 929
• Program Type: Oral and Poster Abstracts
• Date and Time: Saturday, December 11, 2021, 5:30 - 7:30 PM Eastern Time (ET)
• Authors: Hyuna Lee, Hyerin Jang, Yeonsoo Kim, et al.

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About the SB12 Phase 1 study
In the double-blind, three-arm, parallel group, and single-dose study, 240 healthy people were randomized in a ratio of 1:1:1 to receive a single 300 mg dose of either SB12, EU-sourced eculizumab, or US-sourced eculizumab via IV infusion for 35 minutes. Blood samples for PK and PD analysis were collected over 64 days. Primary PK endpoint was the area under the concentration-time curve from time zero to infinity (AUCinf). Secondary PK endpoints were area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) and maximum observed concentration (Cmax). PD endpoints were change in terminal complement activity over time. Safety and immunogenicity endpoints were adverse events (AEs) and serious AEs (SAEs), incidence of ADAs, NAbs to eculizumab, and clinical laboratory, vital signs, 12-lead electrocardiogram (12-lead ECG). 

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing health care that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology, and gastroenterology. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.

MEDIA CONTACT
Anna Nayun Kim, Global Communications, Samsung Bioepis
nayun86.kim@samsung.com 

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ⁱ  Soliris is registered trademark of Alexion Pharmaceuticals, Inc.
ⁱⁱ The U.S. Food and Drug Administration. Soliris® Prescribing Information.   
   https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125166s172lbl.pdf