“It is with great satisfaction we can announce that our first clinical trial application has been submitted to the first national regulatory authority,” said Xbrane’s CEO, Martin Amark, in a statement.
This will be the first potential biosimilar studied by Xbrane after it announced in September 2018 that the company was shifting its focus from generic drugs to biosimilars. “The board of directors of Xbrane has decided to dedicate the absolute majority of the company’s development resources to biosimilars going forward,” read the announcement.
Since then, the ranibizumab product has demonstrated high similarity previous in vitro and in vivo studies. In October 2018, Xbrane released data from its in vivo study conducted in rabbits that found that the product demonstrated an equivalent pharmacokinetic profile and equivalent tolerability to the reference. Additionally, eyes treated with the biosimilar did not show any ocular inflammation.
The Xplore trial is designed as a phase 3 trial to confirm biosimilarity of the proposed biosimilar to the reference product in terms of safety, efficacy, and immunogenicity. The study will look to enroll about 600 patients across 150 sites in 16 countries. The primary end point is defined as the change in visual acuity after 8 weeks of treatment. In order to measure this success, the confidence interval of the difference between the potential biosimilar and the reference need to fall within a predefined equivalence margin.
Xbrane expects that submission of the clinical trial applications to other countries will be completed over the course of the next 1 to 2 months.
“The start of the trial is planned for March 2019 when we also expect to recruit our first patient. After having demonstrated high similarity in vitro and in vivo to the originator, it is with great excitement and confidence that we enter into this pivotal phase 3 trial with Xlucane,” said Amark.