Samsung Bioepis Co., Ltd. announced today that the primary endpoints have been met in the randomized, double-masked, phase 3 trial comparing the efficacy, safety and immunogenicity of SB11, a ranibizumab biosimilar candidate, to reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD).
“We are excited to share this news on the development of our first treatment for ophthalmic diseases,” said Seongwon Han, Medical Team Leader at Samsung Bioepis. He continued, “These 24-week interim results suggest that SB11 will be a valuable treatment option for nAMD, potentially helping millions of patients worldwide.”
The study achieved its primary endpoints which were the change from baseline in best corrected visual activity (BCVA) at Week 8 and central subfield thickness (CST) at Week 4. The least squares (LS) mean change in BCVA was 6.2 letters for SB11, compared with 7.0 letters for reference ranibizumab. The LS mean change in CST was −108.4 μm for SB11 vs −100.1 μm for reference ranibizumab. The confidence interval (CI) of the difference between the two treatments in BCVA and CST was within the predefined equivalence margins.
The incidence of treatment-emergent adverse events was 66.0% for SB11 and 66.9% for reference ranibizumab. The overall incidence of anti-drug antibodies was low (3.0% for SB11 vs 3.1% for reference ranibizumab). Pharmacokinetic (PK) serum concentrations also appeared comparable.
This data was to be presented at Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2020 which has been cancelled due to COVID-19.
Samsung Bioepis announced in November 2019 that it has entered into a new commercialization agreement with Biogen (Nasdaq: BIIB) for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the United States (US), Canada, Europe, Japan, and Australia.
SB11 Phase 3 Study
The SB11 Phase 3 study was a randomized, double-masked, multicenter study evaluating the efficacy, safety, PK, and immunogenicity of SB11 compared to reference ranibizumab in patients with nAMD. 705 patients were randomized (1:1) to receive SB11 or reference ranibizumab in monthly injections (0.5 mg). The primary endpoints were BCVA and CST. Equivalence was declared if the two-sided 90% CI of the difference of the LS mean change from baseline in BCVA at Week 8 between two treatments was within the pre-defined margin of ± 3 letters and if the two-sided 95% CI of the difference of the LS mean change from baseline in CST at Week 4 between two treatments was within the pre-defined margin of ± 36 μm. Secondary endpoints were safety, PK, and immunogenicity.
nAMD is a form of age-related macular degeneration (AMD); a disease that impacts the central area of the retina in the eye (the macula). AMD is a leading cause of blindness in people aged 60 and over,ii however many people do not immediately recognize the symptoms, mistaking it for a normal sign of ageing. This leads to the more severe condition, nAMD, where new and abnormal blood vessels grow uncontrollably under the macula, causing swelling, bleeding and fibrosis.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare 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 and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.
i Lucentis® is a registered trademark of Genentech Inc
ii Age-related macular degeneration, WebMd. https://www.webmd.com/eye-health/macular-degeneration/age-related-macular-degeneration-overview#1 [Accessed May 2020]