Xbrane Biopharma has received approval from the US Food and Drug Administration (FDA) and the Central Ethics Committee to begin the Phase III Xplore trial to assess xlucane in comparison with lucentis for the treatment of patients with the wet form of age-related macular degeneration (wAMD).
Xlucane is a ranibizumab (lucentis) biosimilar candidate created by xbrane.
The approval is based on an investigational new drug (IND) application submitted by xbrane.
Xbrane Biopharma CEO Martin Åmark said: “Applications to the additional countries are being submitted continuously during January and February. First patient in is expected for March 2019.”
Xbrane intends to establish biosimilarity in terms of safety, efficacy and immunogenicity of xlucane against Lucentis in the wAMD patients.
The company framed the design of the trial in consultation with the US FDA and the European Medicines Agency (EMA).
The trial is expected to enroll around 600 patients at approximately 150 sites in 16 countries.
Its primary efficacy objective is a change in visual acuity after eight weeks of treatment evaluated on the basis of the confidence interval of the difference between xlucane and lucentis within a pre-defined equivalence margin.
Secondary objectives of the trial comprise efficacy, safety and immunogenicity during the complete treatment period of 12 months.
Xbrane has also contracted CRO Syneos Health to conduct the Xplore trial, which aims to help the company with the registration of Xlucane across most of the regions.