In light of the ongoing COVID-19 pandemic, we are committed to keeping our stakeholders informed as the situation evolves. We see the following impact at this point in time:
Galapagos has strong measures in place to help prevent spread of the virus and protect the health of our staff. We rolled out our global and site business continuity plans and took appropriate recommended precautions and restrictions, including suspending almost all travel. In practice, this means that most of our employees are working from home, with the exception of lab personnel and skeleton IT and facility team to ensure safety and operational continuity essential to keep research going. For those employees, we have stringent cleaning and sanitation protocols in place, and we strictly respect social distancing policies at all times, in order to minimize risk of exposure.
- Clinical trials
We have a business continuity plan for our non-clinical studies and clinical trials, including a pandemic response plan. Given the pandemic, we decided to pause the start of early stage trials temporarily, but are currently planning to initiate them in the second half of the year, including the Phase 2 Toledo trials with GLPG3970. We continuously monitor the situation, always putting patients’ safety and needs front and center, and our teams are working hand in hand with our CROs and clinical trial sites to define next steps. Our collaboration partner Gilead is restarting enrollment into the filgotinib trials at select clinical trial sites, always keeping patients’ safety in mind. This includes the Phase 2 and Phase 3 trials of filgotinib in Crohn’s disease (DIVERSITY), the Phase 3 in psoriatic arthritis (PENGUIN), and the Phase 2 trial in uveitis. While the MANTA and MANTA-RAy trials are fully recruited, we cannot exclude potential delays in read-outs in light of COVID-19.
- Filgotinib in RA – filing process
Regulatory decisions in the U.S. and Japan are expected before year-end. As with all applications, but particularly during these difficult circumstances, potential approval timings are subject to change. Gilead also confirmed that all sites involved in the manufacturing of filgotinib are established sites that manufacture Gilead marketed products, are in good standing with the FDA, and are GMP certified.
- Commercial organization
Build-up of our commercial operations in the EU5 countries and the Benelux to prepare for the potential launch of filgotinib continues as planned.