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Wall Street is buzzing about Gilead's rheumatoid arthritis drug. Here's why



Shares of Belgian biotechnology Galapagos NV increased 24% Friday after the company, along with pharmaceutical giant Gilead Sciences Inc. announced that two phase 3 trials on their study rheumatoid arthritis drug had achieved their primary endpoints.

But what really had Wall Street excited was the fabric's safety profile. Filgotinib is an oral, selective JAK inhibitor, a class of drug that has been killed for safety reasons. JAK inhibitors, including Eli Lilly & Co's

LLY, + 0.63%

Olumiant and Pfizer Inc. p

PFE, + 0.43%

Xeljanz, may have serious side effects, including an increased risk of serious infections, malignancies and in Olumiant's case for cardiovascular events such as deep vein thrombosis and pulmonary embolism.

But filgotinib, like Galapagos

GLPG, + 22.52%

evolves with Gilead

GILD, + 2.07%

showed promising safety data, while showing similar efficiency to competitors.

Gilead shares accounted for 2.8% in afternoon trading. Galapagos US listed shares were about to close at the highest level since September 2018.

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"FINCH 1 & 3 confirms filgotinib's best safety profile", wrote JP Morgan analysts on a note Friday referring to the two trials by name.

In one study, the researchers examined filgotinib alone and in combination with methotrexate, a pill, in patients who had never previously been treated with methotrexate. After 24 weeks, a greater proportion of patients on combination therapy showed a greater than 20% improvement in the number of sore and swollen joints (a measure called ACR20, which was the primary endpoint of the study) than those alone on methotrexate.

In another experiment, the researchers investigated how two different doses of filgotinib opposed AbbVie Inc.

ABBV, + 0.79%

most sold Humira or methotrexate. This time, patients enrolled in the study were already treated with methotrexate but did not respond adequately to the drug. After 12 weeks, the proportion of patients receiving ACR20 was higher in the filgotinib group than in the methotrexate group. However, in most measures, patients on filgotinib showed no statistically significant improvement over those on Humira. Exception: A larger proportion of patients on filgotinib achieved clinical remission than in Humira.

What really became Wall Street's eye was filgotinib's security data. Data from three phase 3 studies showed that among patients already receiving methotrexate, 1.5% of those who received the higher dose of filgotinib had serious infections as a side effect compared to 2.5% of those receiving Humira. And none of the patients on the higher dose of filgotinib had malignancies compared to 0.3% of those in Humira.

The safety profile of filgotinib is important for investors. There are other JAK inhibitors on the market and the food and drug administration is undergoing a new drug application, which AbbVie submitted in December to its own JAK inhibitor called upadacitinib. Filgotinib's safety data is what can distinguish it from each other.

"As filgotinib is likely to be the fourth JAKi to the market, a clean security profile could help drive usage," Jefferies analysts said in a Friday context.

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Some analysts were excited about how filgotinib's safety data compared to AbbVies upadacitinib. The Gilead and Galapagos trials did not compare filgotinib directly with upadacitinib, but J.P. Morgan said they believed filgotinib's safety data to be stronger, especially when it comes to deep vein thrombosis and pulmonary embolism.

However, unlike filgotinib, upadacitinib showed better effect than Humira on several measures, "there could be a small market disruption for filgotinib," wrote J.P. Morgan analysts.

Filgotinib's experimental results come at a time when Gilead, in conjunction with moving hepatitis C drug sales, is seeking new ways to expand its business. Stocks in the pharmaceutical giant have fallen 13% over the past 12 months, while S & P 500

SPX, + 0.67%

has become 7%. Galapagos shares have increased by 19%.


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