Tony Hagen is senior managing editor for The Center for Biosimilars®.
A Swedish company that wants to bring a ranibizumab biosimilar to market said it may finish trial enrollment despite the pandemic.
A Swedish company is racing against the coronavirus disease 2019 (COVID-19) to complete clinical trials of its ranibizumab biosimilar candidate.
Xbrane said its candidate for age-related macular degeneration needs to complete enrollment in the Xplore trial by the end of the third quarter of 2020 to meet its target date for a regulatory filings.
The biosimilar would carve out market share from Novartis’ blockbuster drug Lucentis, which loses its patent exclusivity in the United States this year and in Europe in 2022. Lucentis earned slightly $2 billion outside the US market in 2019.
COVID-19 has been wreaking havoc on clinical trials, forcing modifications to accommodate for patients’ inability to get to clinics and to prevent COVID-19 infections from compromising trial outcomes. However, Xbrane said that due to the locations of its clinical trial operations and the progress it has made so far, it is “on track” toward approval of Xlucane ahead of the European expiration of Lucentis’ patent in 2022.
“Xbrane is supporting the clinics to take all measures possible to ensure patient safety in relation to visit,” the company said in a release.
Xplore Has Recruited 61% of its Target Population
The Xplore trial has recruited 355 (61%) of 580 planned patients so far, and some of these have been brought aboard in just the past month. However, the company predicted that COVID-19 will cause a reduced recruitment rate. Until recently, Xbrane had been bringing patients onto the trial at the rate of 60 to 80 per month.
“Since the situation changes so rapidly any forecasting of recruitment rates in the coming months becomes challenging,” the company said.
Xbrane has agreements with the European Medicines Agency and the FDA to submit marketing authorization applications (Biologics License Application in the United States) when the last patient enrolled has reached month 6 in the treatment schedule.
The company said that although it is racing against the spread of COVID-19, it is putting patient and clinician safety first. “Xbrane will ensure the safety of Xplore study participants as well as the integrity of study data during the COVID-19 pandemic by following recommendations set by the EMA and the FDA,” the company said.
Meantime, the company also intends to continue treatment for all patients currently enrolled in the study.
Macular degeneration if not treated leads to significant vision impairment; the worst case scenario is blindness. So, despite the risk of trial results being compromised by COVID-19, the company feels the Xplore trial must continue if possible.
Nonurban Trial Locations May Be Beneficial
“Participation in Xplore does not lead to significantly more visits to a clinic than if the patients would receive standard treatment outside of a clinical trial,” Xbrane said.
One advantage to running this trial is that over 50% of the participating clinics are private eye clinics located independently from general hospitals and so the threat of COVID-19 infection is lower in theory, Xbrane said in its release.
Approximately 42% of enrolled patients are based in Eastern Europe, 20% in India, 10% in Israel, 6% in Russia and Ukraine, 14% in the United States, and 8% in Spain.
Xbrane’s headquarters is in Solna, just outside of Stockholm, and the company has research and development facilities in Sweden and in Italy. The company describes itself as a biosimilar development company that looks to exploit niche markets.