GSK Drug for Rare Disease-Related Itch Meets Goal in Phase III Study

GSK plc GSK announced positive headline data from the phase III GLISTEN study, which is evaluating its investigational targeted inhibitor of the ileal bile acid transporter (IBAT), linerixibat, for treating adult patients with cholestatic pruritus associated with primary biliary cholangitis (PBC).The global GLISTEN study met its primary endpoint by showing that treatment with linerixibat led to a statistically significant improvement in monthly itch score as compared with placebo over 24 weeks.Per management, if successfully developed, linerixibat has the potential to become the first therapy indicated for treating itch associated with PBC globally.Year to date, shares of GSK have lost 9.7% compared with the industry’s decline of 11.1%.Image Source: Zacks Investment ResearchMore on GSK's GLISTEN StudyThe preliminary safety data from the ongoing GLISTEN study were similar to those seen in previous studies on linerixibat.Full data from the GLISTEN study is expected to be presented at a medical conference in the future.Cholestatic pruritus (relentless itch) is one of the most common symptoms of PBC, a rare autoimmune disease that might lead to liver failure.Per the press release, by the year 2030, patients diagnosed with PBC will reach 510,000 globally and over 240,000 people will experience relentless itch, for which there is currently no cure.Other Players in the PBC MarketGiven the high unmet medical need, a few other companies are also developing treatments for PBC, as there remains a high unmet medical need.In August 2024, the FDA granted accelerated approval to Gilead Sciences’ GILD seladelpar for the treatment of PBC, in combination with ursodeoxycholic acid (UDCA), in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.The candidate was approved under the brand name Livdelzi.Seladelpar was added to GILD’s portfolio/pipeline through the acquisition of CymaBay Therapeutics Inc. for $4.3 billion in March 2024. The approval of Livdelzi strengthened GILD’s liver disease portfolio.Small biotech Mirum Pharmaceuticals MIRM is developing its pipeline candidate, volixibat, also an oral IBAT inhibitor, for the treatment of PBC.The phase IIb VANTAGE study is currently evaluating MIRM’s volixibat for treating PBC.In June 2024, Mirum announced positive interim data from the VANTAGE study, which showed that treatment with volixibat led to statistically significant improvement in pruritus as well as meaningful reductions in serum bile acids and also an improvement in fatigue.GSK's Zacks Rank & Key PickGSK currently carries a Zacks Rank #4 (Sell).A better-ranked stock in the biotech sector is Castle Biosciences, Inc. CSTL, carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 29.3%.CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.Zacks' Research Chief Names "Stock Most Likely to Double"Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.This top pick is among the most innovative financial firms. With a fast-growing customer base (already 50+ million) and a diverse set of cutting edge solutions, this stock is poised for big gains. Of course, all our elite picks aren’t winners but this one could far surpass earlier Zacks’ Stocks Set to Double like Nano-X Imaging which shot up +129.6% in little more than 9 months.Free: See Our Top Stock And 4 Runners UpWant 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 GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis Report Mirum Pharmaceuticals, Inc. (MIRM): Free Stock Analysis Report Castle Biosciences, Inc. (CSTL): Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks