CEO Onno van de Stolpe and Elizabeth Goodwin, VP Investor Relations
Management does not anticipate a delay in the filgo RA PDUFA date (est. August 2020).
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.
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. In July 2018, we announced the design for the PINTA Phase 2 trial with GLPG1205 in IPF, and recruitment was completed in January 2020. GLPG1205 is a GPR84 inhibitor discovered by and fully proprietary to us. GLPG1205 showed a reduction in signs and symptoms in IPF animal models and has shown favorable tolerability in healthy volunteers and in ulcerative colitis patients in previous trials. We expect to report topline results from PINTA in the second half of 2020.
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
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.
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.