Xbrane announces positive top-line results from the pivotal phase III equivalence trial for Xlucane™ – a biosimilar candidate to Lucentis®
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Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") (Nasdaq Stockholm: XBRANE) today announced top-line results from the 12-months data from the Phase III equivalence trial Xplore with the Lucentis® biosimilar candidate Xlucane™, these data support the ongoing registration process for Xlucane™. As previously announced, Xlucane™ met the primary endpoint demonstrating equivalent efficacy in the change of BCVA (Best Corrected Visual Acuity) at week 8 of treatment compared to Lucentis®. Further, the full 12-months data, as per Xbrane´s assessment, reveals no clinically meaningful differences between Xlucane™ and Lucentis®.
“These results from the pivotal Xlucane™ phase III study represents a significant milestone for Xbrane to become a leading global biosimilar developer,” said Xbrane’s Chairman of the Board, Anders Tullgren.
As communicated on June 27, 2021, based on an interim-read out, Xlucane™ met the primary endpoint in Xplore demonstrating equivalent efficacy measured in improvement in BCVA at week 8 compared to Lucentis®. Equivalence was determined since the two-sided 95% confidence interval around the difference in change in BCVA at week 8 between Xlucane™ and Lucentis® was within the pre-defined equivalence margin as agreed with the EMA and FDA.
The last patient had their last visit in November 2021 and the full 12-months data from all patients in the study has now been compiled and analyzed. As per Xbrane´s assessment, the Xplore study reveals no clinically meaningful differences regarding efficacy, safety, pharmacokinetics, and immunogenicity between Xlucane™ and Lucentis®.
“I would really like to thank all of the clinics and patients who took part in Xplore for making this possible despite the ongoing COVID-19 pandemic,” said Xbrane’s CEO Martin Åmark
Xlucane™ is a biosimilar candidate to Lucentis®, a VEGF-a inhibitor used in the treatment of serious eye diseases, mainly wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The market for oftalmic VEGFa inhibitors generates net-sales of about €10 billion annually.
Xplore is a randomized, double-blinded, multi-center study evaluating efficacy, safety, pharmacokinetics, and immunogenicity of Xlucane™ compared to Lucentis® in patients with wAMD. The primary endpoint in the study is the change in BCVA at week 8. wAMD patients were randomized (1:1) to receive monthly injections of Xlucane™ or the reference product, Lucentis®, for a duration of one year. Around 140 clinics in 15 countries contributed to the successful recruitment of the 583 patients in November 2020, despite the challenges due to the COVID-19 pandemic.