The first new treatment in 60 years! GSK returning bile acid transporter inhibitor linerixibat treats bile depressive itching with remarkable efficacy!

November 16, 2020 // -- GlaxoSmithKline (GSK) recently announced further advances in the development of pipelines and demonstrated clinical data for linerixibat.
the drug is an IBAT inhibitor for bowel bile acid transporter and is currently being developed for the treatment of bile itching in patients with primary bile bile bile bileitis (PBC).
2b GLIMMER study, published as a new summary in River Meeting®2020, showed that linerixibat significantly improved itching (bile siltation itching) in some treatment groups compared to placebos.
data show that linerixibat has the potential to relieve bile siltation itching in PBC patients by targeting bile acid re-ingestion.
GSK has plans to launch Phase 3 clinical studies in 2021, and linerixibat has the potential to become the first new treatment for PBC bile itching in 60 years.
itching of bile in PBC is a serious unsopseed disease and there have been no new pharmacological therapies since the 1960s.
patients with bile siltation can have persistent, intense, deep itching, which is difficult to relieve by scratching.
other data show that bile silt itching has a significant impact on many aspects of a patient's quality of life: fatigue, social, emotional, cognitive and other symptoms.
Christopher Corsico, Senior Vice President, Development,
GSK, said: "There has been no new therapeutic advance in PBC bile itching over the past 60 years, and these data suggest that linerixibat has the potential to mitigate the degenerative effects of bile itching caused by primary bile bile bile bileitis.
GLIMMER study also marks the first time we have worked with 23andMe to support patient recruitment.
as we plan to conduct Phase 3 research, we are pleased to explore the impact of linerixibat further.
" PBC (Photo: Genfit.com) GLIMMER is the largest survey of the population to date.
147 patients received 12 weeks of double-blind treatment, including a placebo, linerixibat 20, 90, 180 mg once a day, or 40, 90 mg twice a day.
study, patients recorded itching on a digital scale every day.
GLIMMER is GSK's first study to use 23andMe to help identify, recruit and group patients.
23andme identified patients who might be eligible and chose to participate in the study.
about 80% of 23andMe customers agree to participate in the study and are eligible to receive information about clinical trials.
23andMe pushed multiple patient referrals to the study just 2 weeks after contacting potential qualified customers.
although the initial analysis of the average change in itching compared to baseline examination after 12 weeks of treatment in the population did not achieve a statistically significant difference, there were three linerixibat dose groups (40mg, 90mg 2 times a day; 180mg daily) There was a significant improvement in itching symptoms compared to the placebo group (N=22, 22, 24 vs placebo group N=36, p=0.011,0.037,0.042, respectively).
encouragingly, there was a significant difference between itching and placebo in patients with moderate to severe itching (baseline itching NRS≥4) in the 40 mg group 2 times a day (N=15 vs placebo N=24, p=0.037).
of this dose of linerixibat also showed significant improvements in quality of life measurements in the general population, including the social and emotional areas of the disease-specific patient reporting tool PBC-40.
chemical structure (Photo: medchemexpress.cn) The most common adverse events due to the mechanism of the role of linerixibat are diarrhea and abdominal pain.
safety and tolerance are considered acceptable and can proceed with phase 3 planning.
Cynthia Levy, M.D., of the Miller School of Medicine at the University of Miami, said: "The GLIMMER study offers some hope for PBC patients with bile itching.
important study highlights the potential of linerixibat as a future treatment for severe itching, which is expected to have a positive impact on quality of life.
", based on these 2b-phase data, GSK is preparing to conduct Phase 3 studies and work with 23andMe to help determine which patients are eligible for the program, which it hopes will significantly reduce recruitment time.
() Original origin: GSK presents Phase 2b data on linerixibat for the treatment of cholestatic pruritus in primary biliary cholangitis (PBC)