Gilead Sciences, Inc. (GILD - Free Report) and partner Galapagos NV (GLPG - Free Report) announced positive topline results from a late-stage study on its investigational, oral, once-daily, selective JAK1 inhibitor filgotinib.
The topline results showed that a higher dose of the candidate achieved the desired results. Filgotinib 200 mg demonstrated greater efficacy compared with placebo in the induction and maintenance of remission in the SELECTION study. The study data showed early response for filgotinib as an induction therapy and the durable efficacy as maintenance therapy.
The randomized, double-blind, placebo-controlled phase IIb/III study is evaluating the efficacy and safety of filgotinib in 1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis (UC) — a chronic, idiopathic inflammatory disease affecting the colon that often involves periods of remission interspersed with periods of active disease.
Filgotinib 200 mg achieved all primary endpoints in the study, inducing clinical remission at week 10 and maintaining clinical remission at week 58 in a significantly higher proportion of patients compared with placebo. However, filgotinib 100 mg did not achieve statistically significant clinical remission at week 10.
Clinical remission in the study was defined as an endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and ≥ 1 point decrease in stool frequency from baseline to achieve a subscore of 0 or 1.
Among the biologic-naïve cohort (Cohort A induction trial; n=659), 52% of patients had a baseline Mayo Clinic Score (MCS) of nine or higher. A baseline MCS of nine or higher was noticed in 74% of patients, while 51% were previously treated with two different classes of biologics (TNFα antagonists and an integrin receptor antagonist) in the biologically-experienced cohort (Cohort B induction trial; n=689).
Patients who achieved clinical response or remission after 10 weeks of treatment with filgotinib 100 mg or 200 mg were subsequently re-randomized to their induction dose of filgotinib or placebo in a 2:1 ratio and treated through week 58 (maintenance trial, n=558). Both doses of filgotinib achieved the primary endpoint in this maintenance trial. At week 58, 37.2% of biologic-naïve and biologic-experienced patients receiving filgotinib 200 mg achieved clinical remission compared with 11.2% treated with placebo.
Of the patients receiving filgotinib 100 mg, 23.8% achieved clinical remission at week 58, compared with 13.5% treated with placebo.
Moreover, rates of serious infections, herpes zoster, venous thrombosis, pulmonary embolism and gastrointestinal perforation were low and comparable across treatment groups in both the induction and maintenance phases of the study.
Detailed results will be presented later.
We remind investors that filgotinib is currently under review in the United States and Europe for the treatment of rheumatoid arthritis.
A potential approval will diversify Gilead’s portfolio as it focuses on HIV business and other new avenues to combat the dwindling HCV business. Moreover, the HIV business faces stiff competition from ViiV Healthcare, a joint venture of Glaxo (GSK - Free Report) and Pfizer (PFE - Free Report) .
The candidate is also being evaluated in Crohn’s disease, in psoriatic arthritis as well as in uveitis and in small bowel and fistulizing Crohn’s disease.
Gilead’s stock has gained 13.7% so far this year compared with the industry's growth of 6.5%.
The stock has been in the news from the onset of the year due to its promising experimental coronavirus drug, remdesivir. A positive outcome from studies on remdesivir will be a significant boost for the company.
Gilead currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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