GSK plc (LSE/NYSE: GSK) has announced positive results from its phase III GLISTEN trial of linerixibat, an investigational drug aimed at treating cholestatic pruritus (persistent itching) in patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. The trial met its primary endpoint, showing a statistically significant improvement in itch over 24 weeks compared to placebo.
The GLISTEN trial recruited PBC patients experiencing moderate to severe itch, some of whom were treatment-naïve or had been previously treated, while others were receiving stable doses of guideline-suggested therapies for pruritus. The preliminary safety results align with those from prior studies. Detailed analysis of the data is ongoing, with full results expected to be presented at a future scientific congress.
Kaivan Khavandi, SVP & Global Head of Respiratory/Immunology R&D at GSK, highlighted the potential of linerixibat to become the first global therapy specifically developed to treat itch in PBC, which could significantly improve patients' quality of life.
PBC affects the liver's bile ducts, leading to excess bile acids that are believed to cause cholestatic pruritus. Up to 90% of people with PBC experience this symptom, which can be severe and impact sleep, mental health, and overall quality of life. The disease has no cure, and current treatments do not adequately address the severity of the itch.
Linerixibat has been granted Orphan Drug Designation in the US and EU. It is designed to inhibit the ileal bile acid transporter (IBAT), thereby reducing bile acid re-uptake and potentially addressing a root cause of the itch associated with PBC.
The GLISTEN trial is a double-blind, randomized, placebo-controlled study that included a crossover design for participants. The trial's primary and secondary outcomes were assessed using itch-related measures and quality-of-life questionnaires.
As of now, linerixibat is not approved for use. The information in this article is based on a press release statement from GSK plc.
In other recent news, GlaxoSmithKline (NYSE:GSK) has been the subject of attention from financial analysts. Jefferies downgraded GSK stock from 'Buy' to 'Hold', adjusting its price target to INR 15.25. This decision was influenced by expectations of subdued growth for the company in 2025, due to potential challenges for Arexvy & Shingrix, and the US Medicare Part D redesign.
Guggenheim also downgraded GSK stock from Buy to Neutral, expressing concerns about the company's pipeline catalysts and sales/earnings per share projections up to 2025.
Furthermore, GSK reported a strong performance in its third-quarter earnings call, with a 9% sales growth and a 19% profit growth year-to-date. The company's Specialty Medicines division, particularly in HIV, respiratory immunology, and oncology, drove a 2% sales increase for the quarter.
Despite a decline in vaccine sales, GSK confirmed a full-year guidance of 7% to 9% sales growth and 11% to 13% profit growth.
These are recent developments in the company's financial performance and outlook.
InvestingPro Insights
GSK's positive phase III trial results for linerixibat align with the company's strong position in the pharmaceutical industry. According to InvestingPro data, GSK boasts a market capitalization of $67.22 billion and has maintained a solid revenue of $41.86 billion over the last twelve months as of Q3 2024. The company's gross profit margin stands at an impressive 72.39%, reflecting its ability to efficiently manage costs in drug development and production.
InvestingPro Tips highlight GSK's financial stability and market position. The company has maintained dividend payments for 24 consecutive years, demonstrating a commitment to shareholder returns. This is particularly relevant given the potential success of linerixibat, which could further strengthen GSK's product pipeline and financial performance.
Additionally, GSK's valuation implies a strong free cash flow yield, which could provide the company with resources to continue investing in innovative treatments like linerixibat. For investors interested in a deeper analysis, InvestingPro offers 11 additional tips that could provide further insights into GSK's investment potential.
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