- Fresh data appears to have propped up investor optimism in an anti-inflammatory drug from Gilead Sciences and Galapagos, as both biotechs experienced stock gains in after-hours trading Tuesday.
- The FINCH-2 trial tested 100 mg and 200 mg doses of filgotinib against placebo in adults with moderate-to-severe rheumatoid arthritis who either can't take or haven't adequately responded to biologic therapies. Results showed filgotinib met the trial's primary endpoint, with significantly more patients in both experimental arms achieving ACR20, a measure of disease activity, than in the control arm by week 12.
- Analysts noted that safety would be a focal point of the readout because of looming concerns that Janus kinase (JAK) inhibitors — a class of drugs that includes filgotinib — may affect blood clotting. Yet, Gilead and Galapagos said no reports of deep venous thrombosis (DVT) or pulmonary embolism (PE) have come out of FINCH-2 thus far.
Gilead's declining hepatitis business has taken with it considerable investor support. By Tuesday's market close, shares were trading at $72.23 apiece — far from the biotech's 52-week high of $89.54 apiece and well below the 2015 peak of near $120.
Despite those concerns, Wall Street analysts have recently noted Gilead is becoming more stable as its flagship drugs Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) bottom out. Moving forward, the company has a few near-term growth opportunities, one of which is filgotinib.
"The good news is this is the first positive study and helps to de-risk the initial readouts for the franchise and looks pretty clean," Michael Yee of Jefferies wrote in a Sept. 11 investor note, referring to the FINCH-2 results. "We see this as a modest but good catalyst for [Gilead] given recent stock performance over the last few months and some frustrated investor sentiment."
Yee highlighted that, in FINCH-2, filgotinib's efficacy was on par with competitor drugs developed at Eli Lilly and AbbVie. On the study's primary endpoint, 57.5% of patients taking filgotinib 100 mg and 66% of patients taking filgotinib 200 mg experienced ACR20 by week 12, significantly higher than the 31.1% of patients who did in the placebo group.
Aside from hitting FINCH-2's primary endpoint, both doses of filgotinib also significantly outperformed placebo on ACR50 and ACR70 (which represent higher thresholds of disease improvement) as well as measures of low disease activity and clinical remission.
More important than the efficacy, however, was the fact that Gilead and Galapagos' drug maintained a fairly clean safety profile throughout the study. There were no patient deaths or cases of opportunistic infections, and the proportion of patients who discontinued due to treatment-emergent adverse events was similar across all three of the study's arms.
And though investigators did record two major adverse cardiovascular events, one of them was in the placebo group.
The safety data is important for two reasons. One is that it strengthens filgotinib's competitive standing against AbbVie's potential rival upadacitinib. The other is that regulators had major issues with the potential side effects of Lilly's recently approved JAK inhibitor Olumiant (baricitinb) — issues that some have noted may translate across the drug class.
"We had concluded that filgotinib does indeed appear to be the most JAK1 selective of this class, and was therefore destined to have the cleanest safety profile, but this result, and the subsequent presentations and trials, will be important to confirm that differentiation," Leerink analyst Geoffrey Porges wrote in a Sept. 12 note.
"At least based on the companies’ press release last night, this hypothesis is indeed valid and supports the notion that while filgotinib may not be the first of these drugs to market (likely the last), it might be the best," he added.
Two more trials testing filgotinib in rheumatoid arthritis patients, FINCH-1 and FINCH-3, are set to read out in the first half of 2019.
"These data are particularly encouraging as we look ahead to Phase 3 results from the ongoing FINCH 1 and 3 trials, which are exploring filgotinib in other populations of patients with rheumatoid arthritis," John McHutchison, Gilead's chief scientific officer and head of R&D, said in a Sept. 11 statement.
Shares in Gilead rose 2.5% to $74 apiece on the heels of the FINCH-2 announcement, while Galapagos stock climbed 5.5% to $102.74 per share. By Wednesday's market open, Gilead shares were trading at $75.06 apiece while Galapagos shot up to $119.84 apiece.