avantiavanti schreef op 12 november 2019 12:03:
Degroof Petercam 12 november 2019
TP 181 euro
Galapagos (Buy) – Additional filgotinib data at 2019 ACR/ARP Annual
MeetingFacts – Several presentations on arthritisAt the 2019 ACR/ARP Annual Meeting, Galapagos and Gilead present a total of 20 abstracts, including key efficacy and safety data on filgotinib in rheumatoid arthritis (RA).
A subgroup analysis from the Phase III FINCH 2 trial evaluating once-daily doses of filgotinib 200 mg and 100 mg with stable dose of csDMARDs in patients who previously had an inadequate response to biologic DMARD therapy (bDMARD-IR) showed that both doses of filgotinib improved clinical outcomes versus placebo at Week 12, regardless of the number and mechanism-of-action (MOA) of prior biologic used. At Week 24, filgotinib consistently improved clinical outcomes in bDMARD-IR patients. Efficacy was not impacted by demographic and clinical baseline characteristics.
Safety and tolerability of filgotinib as a monotherapy and in combination with MTX or csDMARDs were found to be favorable in a pooled safety analysis across the randomized, multicenter Phase III FINCH 1, 2 and 3 studies encompassing a total of 3,452 patients. Major adverse cardiac events (MACE), herpes zoster virus, deep vein thrombosis (DVT) and pulmonary embolism (PE) were low and well balanced with placebo groups. A separate analysis from the FINCH 2 trial suggests that filgotinib may not increase the incidence of anemia, thrombocytopenia or leukopenia.
Data comprising 2,203 patient-years of exposure (PYE) with filgotinib from the Phase IIb, open-label extension DARWIN 3 study further demonstrated durable safety and efficacy of filgotinib (200 mg or 100 mg) monotherapy and filgotinib plus MTX. No new safety signals were observed through 156 weeks of treatment.
Both companies also present long-term (52 weeks of treatment) safety data on filgotinib of a Phase II open-label extension study in patients with psoriatic arthritis (PsA). In addition, the companies reveal more information on the design of the recently initiated Phase III program in PsA. This comprises two trials, PENGUIN 1 and 2. PENGUIN 1 which will compare the efficacy and safety of filgotinib, adalimumab and placebo in approximately 1000 patients with active PsA who are naive to bDMARD therapy. PENGUIN 2 will measure efficacy and safety of filgotinib vs placebo in 390 patients with active PsA who have an inadequate response or are intolerant to bDMARD therapy. The primary endpoint of each trial is ACR20 response at week 12, with multiple secondary endpoints on signs and symptoms of PsA up to week 24 in PENGUIN 1, and week 16 in PENGUIN 2. Topline readout is expected in 1H22.
Our view – Filgotinib clinical program still holds several potential value inflections in the futureThese additional data and subgroup analyses further support our positive view on filgotinib’s potential as a best-in-class oral JAKi treatment paradigm for RA. The next milestone ahead is regulatory approval in US, EU and Japan. As a small reminder, submissions have been filed in Europe and Japan, NDA submission to the US FDA is anticipated by year-end. We anticipate regulatory feedback and potential market launch in 2H20. We allocate success rate of 95% for filgotinib in RA.
In 2Q20, the first Phase III readout for filgotinib in inflammatory bowel disease (IBD) is expected, more specifically for the SELECTION trial in ulcerative colitis (UC). With AbbVie’s rival JAKi Rinvoq reading out in Phase III only in 2021, filgotinib holds an important time-to-market advantage in UC. We allocate a success rate of 63% to the UC program. The second Phase III readout in IBD is for the DIVERSITY readout in Crohn’s disease (CD), expected in 2021. Compared to UC, CD represents a slightly larger market opportunity as more patients are on active treatment. Based on the positive results obtained in the Phase II FITZROY trial, we allocate a success rate of 68% to the CD program.
Furthermore, we are encouraged by the recent launch of the Phase III PENGUIN trials in psoriatic arthritis (PsA), as the latter represents subtnantial additional market opportunity for filgotinib. We allocate a success rate of 68% to the PsA program. A more or less similar market opportunity could arise for filgotinib ankylosing spondylitis (AS), for which the company anticipates the Phase III launch next year. We allocate a success rate of 57% to the AS program.
Investment conclusionWe maintain our Buy rating.