Gilead Sciences, Inc. GILD and Galapagos NV GLPG announced positive results on pipeline candidate, filgotinib, for the treatment of moderately to severely active ulcerative colitis (UC).
Filgotinib is an investigational, oral, once-daily, JAK1 preferential inhibitor, for the treatment of moderately to severely active UC.
Data from the randomized, double-blind, placebo-controlled, phase IIb/III SELECTION study showed that a significantly higher proportion of patients treated with filgotinib 200 mg, achieved clinical remission at week 10 and maintained remission through week 58 as compared to placebo. In addition, significantly more patients achieved six-month corticosteroid-free remission.
The SELECTION phase IIb/III study is a multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of filgotinib in adult patients with moderately to severely active UC. It included biologic-naïve patients, for whom prior conventional therapy had failed, as well as biologic-experienced patients.
UC is a longer-term condition characterized by inflammation of the mucosal lining of the colon and rectum.
We remind investors that filgotinib (200 mg and 100 mg tablets) is approved in Europe and Japan for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).
Approval in additional indications will boost the sales potential of the drug.
However, both companies suffered a setback when the FDA issued a complete response letter (CRL) for the New Drug Application (NDA) of filgotinib for the treatment of moderately to severely active RA. The agency has now requested data from the MANTA and MANTA-RAy studies before completing its review of the NDA. These studies are designed to assess if filgotinib has an impact on sperm parameters.
Additionally, the FDA has some concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose. Both studies are fully recruited and top-line results are expected in the first half of 2021. The CRL will result in a delay in the approval of the candidate.
The companies are conducting global studies investigating the potential role of filgotinib in a variety of diseases, including the phase III SELECTION study in UC and an actively enrolling phase III study in Crohn’s Disease (DIVERSITY).
Gilead’s shares have lost 1.3% in the year so far against the industry’s growth of 2.6%.
The massive decline in sales of its HCV franchise has prompted it to focus on the HIV franchise, Yescarta and other newer avenues.
However, Jyseleca is likely to face competition from AbbVie’s ABBV Humira and Eli Lilly’s LLY Olumiant, which are already approved as a treatment for RA.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by referendums and legislation, this industry is expected to blast from an already robust $17.7 billion in 2019 to a staggering $73.6 billion by 2027. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot stocks we're targeting >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
Eli Lilly and Company (LLY) : Free Stock Analysis Report
AbbVie Inc. (ABBV) : Free Stock Analysis Report
Galapagos NV (GLPG) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research