The Food and Drug Administration (FDA) and the Central Ethics Committee in the United States have accepted Xbranes IND application for initiation of the Xplore trial, a phase III trial with Xlucane, a ranibizumab (Lucentis) biosimilar candidate.
“It is with great satisfaction we can announce acceptance from the FDA and the Central Ethics Committee to initiate the Xplore trial. Applications to the additional countries are being submitted continuously during January and February. First patient in is expected for March 2019.”, says CEO Martin Åmark.
The Xplore trial
The Xplore trial is a phase III trial designed to confirm biosimilarity with regards to safety, efficacy and immunogenicity of Xlucane versus Lucentis in patients with wet form of age-related macular degeneration (wAMD). The study design was developed in consultation with the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA).
The primary efficacy end-point of the trial is change in visual acuity after eight weeks of treatment, for which the confidence interval of the difference between Xlucane and Lucentis needs to fall within a pre-defined equivalence margin. In addition, several secondary endpoints related to efficacy, safety and immunogenicity are followed over the full treatment period of 12 months.
The study will involve approx. 600 patients across approx. 150 sites in 16 countries and is expected to support the registration of Xlucane across majority of regions globally. Xbrane has for the Xplore trial contracted the global CRO Syneos Health which has conducted some of the largest trials in recent years in the wAMD patient population.