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Phase 2b/3 Trial Shows Efficacy of Filgotinib for the Induction and Maintenance of Remission in Moderately and Severely Active Ulcerative Colitis

— Filgotinib 200mg Achieved Endoscopic, Histologic and Six-Month Corticosteroid-Free Remission at Week 58 with a Consistent Safety Profile —

— Study Enrolled Biologic-Naïve and Biologic-Experienced Patients, a High Proportion of Whom Were Highly Refractory —

Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today presented late-breaking data demonstrating sustained efficacy and safety with filgotinib, an investigational, oral, once-daily, JAK1 preferential inhibitor, for the treatment of moderately to severely active ulcerative colitis (UC). The data from the randomized, double-blind, placebo-controlled, Phase 2b/3 SELECTION trial showed that a significantly higher proportion of patients treated with filgotinib 200 mg, versus placebo, achieved clinical remission at Week 10 and maintained remission through Week 58. In addition, significantly more patients achieved six-month corticosteroid-free remission. The full results were presented today at the 2020 United European Gastroenterology Week (UEGW) Virtual Meeting (Abstracts #LB19 and #LB20).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201012005470/en/

UC is a longer-term condition characterized by inflammation of the mucosal lining of the colon and rectum. An increasingly prevalent disease, UC has a significant impact on the quality of life of more than 2 million people around the world. Despite current treatments, many patients experience fecal urgency, incontinence, recurring bloody diarrhea and the need to empty their bowels frequently, often accompanied by abdominal pain, poor sleep and fatigue.

“There remains a tremendous need for treatments that can achieve meaningful and sustained clinical outcomes in ulcerative colitis,” said Laurent Peyrin-Biroulet, MD, PhD, Gastroenterology Department at Lorraine University in France, and presenting investigator of the SELECTION maintenance study. “These study results showed that filgotinib reduced bleeding and stool frequency while also achieving remission across a range of measures, including endoscopy and histology, in an oral formulation.”

The SELECTION study included biologic-naïve patients, for whom prior conventional therapy had failed, as well as biologic-experienced patients – a high proportion of whom had been non-responders to at least two different lines of prior biologics. In total, 43 percent of patients in the biologic-experienced cohort had failed treatment with both a TNF inhibitor and vedolizumab. The study allowed the enrollment of patients who were taking steroids, and/or immunomodulators, including methotrexate, mercaptopurine (6-MP) or azathioprine, as they would in real-world clinical practice.

Efficacy Data of Filgotinib in Induction and Maintenance

Overall, 1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active UC were randomized and treated in the SELECTION study. Among biologic-naïve patients treated with filgotinib 200 mg, a significantly higher proportion of patients achieved clinical remission at Week 10 compared with placebo (26.1% vs. 15.3%, p=0.0157). Additionally, a significantly higher proportion of biologic-naïve patients treated with filgotinib 200 mg versus placebo achieved Mayo Clinic Score (MCS) remission (24.5% vs. 12.4%, p=0.0053), endoscopic remission (12.2% vs. 3.6%, p=0.0047) and histologic remission (35.1% vs. 16.1%, p<0.0001). A significantly higher proportion of biologic-experienced patients treated with filgotinib 200mg achieved clinical remission at Week 10 compared with placebo (11.5% vs. 4.2%, p=0.0103).

Patients treated with filgotinib who achieved clinical response or

Pancreas size, shape can return to normal in diabetes remission, study says

Reversing type 2 diabetes can restore the pancreas to its normal size and shape, a new study finds.

Previous research found that with remission of type 2 diabetes through significant weight loss, natural insulin-production can return to levels similar to people who have never had diabetes.

The new study is the first to show that reversing diabetes can also affect the size and shape of the pancreas, the researchers said.

The study included 64 people with type 2 diabetes and a control group 64 people without diabetes whose pancreas health was monitored for two years. At the start of the study, average pancreas volume was 20% smaller and organ borders were more irregular in people with diabetes than in the control group.

After five months of weight loss, pancreas volume was unchanged in people with diabetes who’d gone into remission — responders — as well as those who had not. But after two years, the pancreas had grown by an average of one-fifth in responders, but only about 1/12th in non-responders, the findings showed.

Responders also lost a significant amount of fat from their pancreas, at 1.6%, compared with non-responders, at around 0.5%, and achieved normal pancreas borders, the study found.

Only responders showed early and sustained improvement in beta-cell function, which is key to making and releasing insulin. After five months of weight loss, responders were making more insulin and levels were maintained at two years. There was no change in non-responders.

The findings were presented recently at an online annual meeting of the European Association for the Study of Diabetes. Research presented at meetings should be considered preliminary until published in a peer-reviewed journal.

“Our previous research demonstrated the return to long-term normal glucose control, but some experts continue to claim that this is merely ‘well-controlled diabetes’ despite our demonstration of a return to normal insulin production by the pancreas,” said study leader Roy Taylor, a professor of medicine and metabolism at Newcastle University in the United Kingdom.

“However, our new findings of major change in the size and shape of the pancreas are convincing evidence of return to the normal state,” he added.

Taylor noted in an association news release that large amounts of insulin cause tissues to grow or at least maintain their size.

“Normally, inside the pancreas the amounts of insulin present after a meal are very high. But in type 2 diabetes this does not happen. This new study suggests that achieving remission of type 2 diabetes restores this healthy, direct effect of insulin on the pancreas,” Taylor said.

It’s not clear why diabetes remission doesn’t occur in all patients who lose weight, said Elizabeth Robertson, director of research at Diabetes UK, which funded the study.

Type 2 diabetes affects one in 11 — or 415 million — adults worldwide.

More information

The American Diabetes Association has more on type 2 diabetes.

Copyright 2020 HealthDay. All rights reserved.

Pancrease size, shape can return to normal in diabetes remission, study says

Reversing type 2 diabetes can restore the pancreas to its normal size and shape, a new study finds.

Previous research found that with remission of type 2 diabetes through significant weight loss, natural insulin-production can return to levels similar to people who have never had diabetes.

The new study is the first to show that reversing diabetes can also affect the size and shape of the pancreas, the researchers said.

The study included 64 people with type 2 diabetes and a control group 64 people without diabetes whose pancreas health was monitored for two years. At the start of the study, average pancreas volume was 20% smaller and organ borders were more irregular in people with diabetes than in the control group.

After five months of weight loss, pancreas volume was unchanged in people with diabetes who’d gone into remission — responders — as well as those who had not. But after two years, the pancreas had grown by an average of one-fifth in responders, but only about 1/12th in non-responders, the findings showed.

Responders also lost a significant amount of fat from their pancreas, at 1.6%, compared with non-responders, at around 0.5%, and achieved normal pancreas borders, the study found.

Only responders showed early and sustained improvement in beta-cell function, which is key to making and releasing insulin. After five months of weight loss, responders were making more insulin and levels were maintained at two years. There was no change in non-responders.

The findings were presented recently at an online annual meeting of the European Association for the Study of Diabetes. Research presented at meetings should be considered preliminary until published in a peer-reviewed journal.

“Our previous research demonstrated the return to long-term normal glucose control, but some experts continue to claim that this is merely ‘well-controlled diabetes’ despite our demonstration of a return to normal insulin production by the pancreas,” said study leader Roy Taylor, a professor of medicine and metabolism at Newcastle University in the United Kingdom.

“However, our new findings of major change in the size and shape of the pancreas are convincing evidence of return to the normal state,” he added.

Taylor noted in an association news release that large amounts of insulin cause tissues to grow or at least maintain their size.

“Normally, inside the pancreas the amounts of insulin present after a meal are very high. But in type 2 diabetes this does not happen. This new study suggests that achieving remission of type 2 diabetes restores this healthy, direct effect of insulin on the pancreas,” Taylor said.

It’s not clear why diabetes remission doesn’t occur in all patients who lose weight, said Elizabeth Robertson, director of research at Diabetes UK, which funded the study.

Type 2 diabetes affects one in 11 — or 415 million — adults worldwide.

More information

The American Diabetes Association has more on type 2 diabetes.

Copyright 2020 HealthDay. All rights reserved.