Next news flow and Catalysts
mid 2020 Filgotinib
US approval in RA expected - Gilead submitted NDA 19 Dec 2019 and are using a Priority Review Voucher.
Gilead and Galapagos aim to pursue development of filgotinib in 10 to 14 indications, not including the Crohn’s sub-populations.
Broad applicability means multi-blockbuster potential.
• Filgotinib Phase IIb/III SELECTION ulcerative colitis data in 2Q20E for potential filings in 2H20E
• Filgotinib RA approvals and launches across US, EU and Japan from 2H20E
• Phase II data for GLPG1690 in systemic sclerosis (NOVESA) and GLPG1205 in IPF (PINTA) in 3Q20E
• Phase IIb ROCCELLA GLPG1972 osteoarthritis data during 4Q20E
• GLPG1690 Phase III IPF interim futility analysis Late 2020/1Q21E.
Phase IIa NOVESA systemic sclerosis data during 3Q20E;
Phase III ISABELA IPF futility analysis during 1Q21E, with efficacy data from 2022E.
IPF is a core area of focus for Galapagos.
• GLPG1972 Phase II ROCELLA data during 4Q20E triggering Gilead opt-in decision.
• Toledo GLPG3312 proof-of-concept data in ulcerative colitis potentially during 2H20E
Data from 1st Toledo compound (GLPG3312) to read out p1 (NCT03800472) in healthy volunteers in 2H20 (undisclosed target for use in inflammatory diseases) - will start a PoC in 2H20 in ulcerative colitis. Second compound (GLPG3970) entered the clinic in Sep (NCT04106297, SC Nov-20). GLPG3970 will enter multiple PoC p2 trials in 2020.
The Toledo programme aims to improve upon disease control rates achieved with
current standard of care, with applicability across a number of inflammatory diseases. The programme employs a novel mechanism of action, targeting the interplay between dendritic (sensory) cells and epithelial cells. Preclinical data in a number of inflammatory bowel disease (IBD) models and a rheumatoid arthritis (RA) model suggests substantial reductions in disease activity indexes, superior to other drug classes studied, including JAK-inhibitors.
Onno and Galapagos are very enthusiastic about the Toledo programme.
Quotes Onno; Clinical trials: We have a business continuity plan for our non-clinical and clinical trials, including a pandemic response plan. To date, patient visits in our clinical trials have continued with minimal impact.
Filgotinib filing process in RA: to date, our collaboration partner, Gilead, has not been informed by the regulatory agencies in the US, Europe and Japan of approval time line delays. Gilead also confirmed that all sites involved in the manufacturing of filgotinib are established sites that currently manufacture other 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.
We have a very strong balance sheet, thanks to the Gilead deal closed last year, ending 2019 with cash and current financial investments of €5.8 billion. Of course these are challenging times for us, and our share price has been under severe pressure. At the same time, we are confident.
At Galapagos, we have weathered crises before and came out stronger, every time.
The fundamentals have not changed.
In other words, stay tuned for Galapagos 2.0!