CEO Onno van de Stolpe and Elizabeth Goodwin, VP Investor Relations
CEO Fireside Chat Recap: Maximizing Execution in COVID-19
Uncertainty; Filgo UC Data On-Deck; Broad Pipeline Progress
Management does not anticipate a delay in the filgo RA PDUFA date (Stifel est. August 2020). For filgo in UC (data est. 2Q20), cross trial comparisons with competitors may prove challenging due to subtle differences in trial designs/endpoints, but management thinks Rinvoq is most appropriate (~14-20% pbo-adjusted remission).
Non-filgo pipeline, including P3 '1690 and P2 '1205 in IPF, as well as P2b '1972 in OA continue as planned for now, but the situation remains fluid. Street assumes filgo black box given Rinvoq class label, but GLPG internal market research suggests docs will recognize filgo best-in-class safety advantages.
Importantly, management has not seen evidence of a delay in the approval of filgotinib. And while GLPG does not expect an adcom, they did point to the possibility of a virtual adcom, if one were convened.
Filgotinib readout in UC remains on-track for this quarter.
GLPG forging ahead with PoC studies in the backdrop of COVID-19 disruption.
Management was transparent in acknowledging that enrollment in ongoing PoC studies had slowed, but were not prepared to change their guidance (2H20)
GLPG1690: Recruitment continues in the ISABELA P3 study in IPF, and remains on track (futility analysis 1H21). However, management is cognizant of the fluidity of the situation (esp. in the US) and acknowledged that things could change.
The Company continues to closely monitor patients enrolled in the study to minimize pts drop-offs and missing data points (patients are monitored once a month, to once every 3 mos.) GLPG remains on track to report P2 data with ‘1690 in SSc (NOVESA) in 2H20.
GLPG1205: No change – data from the PoC P2 PINTA study in IPF are expected in 3Q20.
GLPG 1972: The Company is in the midst of finishing the P2b ROCCELLA study in OA with data anticipated in 2H20. As a reminder,
quantitative MRI assessment of the target knee is required at the end of the study (NCT03595618), which would require an outpatient visit. Management signaled that the FDA has shown flexibility with respect to study endpoints and protocols. They believe that even if measurements are not taken at the 52 wk time point, and done later, the data points would still be valid.
GLPG sees filgotinib’s safety profile as the main differentiator compared to other JAKi
As we have noted previously, one of the debates around filgotinib is whether it will be able to avoid a black box for thromboembolic events (TE), which is likely a class effect. GLPG believes that the drug’s safety profile is more favorable when put up against its competitors. Management also pointed to their own market research, which suggests that physicians will be able analyze the data and spot the benefits of filgotinib. In UC, GLPG sees the MANTA and MANTA-ray testicular tox studies as important given the prevalence of UC in younger individuals compared to RA, which tends to affect the older population. Management said that it plans to release substantial safety data from the UC study, similar to other data releases (i.e. FINCH trial).
Commercialization build in the EU remains focused.
GLPG is building up its commercial team in Benelux, France, Italy and Spain, and
continue to prepare for the launch of filgotinib in RA. Management recognized that Rinvoq’s launch has gone well (which bodes well for JAKs in the EU), and believes that they may have an advantage over ABBV in the current climate since marketing of Rinvoq has been halted – potentially giving GLPG time to catch up. GLPG also highlighted potential for meaningful uptake of filgotinib and other JAKi in the EU due their rapid onset, oral availability vs. biologic, and lack of ADAs.