Xbrane Biopharma has enrolled all the planned 580 patients in to XPLORE – the phase III trial for its biosimilar candidate Xlucane.
Top-line data from XPLORE is expected to be communicated mid-2021 and filing of the Xlucane Marketing Authorization Application (“MAA”) and Biologics License Application (“BLA”) to European Medicines Agency (“EMA”) and US Food and Drug Administration (“FDA”) respectively will take place short thereafter.
XPLORE’s objective is to demonstrate the equivalent efficacy and safety of the company’s leading product candidate Xlucane compared to Lucentis. XPLORE includes 580 patients with wet age-related macular degeneration. Xbrane Biopharma will conduct an interim read-out from XPLORE when the last patient has reached month six of their treatment schedule and, as has been agreed with both EMA and FDA, file the MAA/BLA based on this interim read-out.
A major milestone
Taking into account the time required to finalise the clinical study report, filing of the MAA/BLA is expected to take place mid-2021. With an expected 12-month regulatory process upon filing, Marketing Authorization is expected in Europe and the US mid-2022 allowing for subsequent launch of Xlucane by Xbrane Biopharma’s partners STADA Arzneimittel AG and Bausch + Lomb.
“We are pleased to be able to conclude enrolment to XPLORE and we are thankful to all the clinics and patients participating. This event is a major milestone for the company. The countdown for filing MAA/BLA now begins as the COVID-19 related enrolment risk has been eliminated,” says Martin Åmark, CEO of Xbrane Biopharma.
Photo of Martin Åmark: Xbrane