GlaxoSmithKline

AI-powered ECG tech and patient-centered solutions are revolutionizing clinical trials, enhancing cardiac safety, data integrity, and trial efficiency. This webcast explores how these innovations align with FDA guidance and improve clinical research practices.

GSK's phase III GLISTEN trial of linerixibat for treating cholestatic pruritus in PBC patients met primary endpoint, showing significant itch improvement over 24 weeks. Linerixibat, granted Orphan Drug Designation in US and EU, inhibits ileal bile acid transporter to reduce bile acid re-uptake. GSK reported 9% sales and 19% profit growth YTD, despite vaccine sales decline, confirming full-year guidance of 7-9% sales and 11-13% profit growth. InvestingPro data shows GSK's market cap at $67.22B and 72.39% gross profit margin.

Fanaroff: Research grants from American Heart Association and National Institutes of Health; consulting fees from Abbott Laboratories. Vora: Consulting fees from Medtronic. Mehran: Institutional research grants from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb/Sanofi, CSL Behring, Eli Lilly/Daiichi Sankyo, Medtronic, Novartis, OrbusNeich; consulting fees from Boston Scientific, Abbott Vascular, Medscape, Siemens Medical Solutions, Roivant Sciences Inc, Sanofi; consulting (no fees) for Regeneron Pharmaceuticals Inc; institutional consulting fees from Abbott Vascular, Spectranetics/Phillips/Volcano Corporation, Bristol Myers Squibb, Novartis, Watermark Research; Executive committee member for Janssen Pharmaceuticals and Bristol Myers Squibb; <1% equity in Claret Medical and Elixir Medical. Granger: Research grants from Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Armetheon, AstraZeneca, US Food and Drug Administration, GlaxoSmithKline, The Medicines Company, Medtronic Foundation, Medtronic Inc, Novartis; consulting fees from Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Abbvie, Armetheon, AstraZeneca, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, The Medicines Company, National Institutes of Health, Novartis, Sirtex, Verseon, Apple, Medscape, LLC, Merck, Novo Nordisk, Roche Diagnostics, Rho Pharmaceuticals. Goodman: Research grant support and/or speaker/consulting honoraria from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Daiichi-Sankyo, Eli Lilly, Esperion, Fenix Group International, Ferring Pharmaceuticals, GlaxoSmithKline, HLS Therapeutics, Janssen/Johnson & Johnson, Luitpold Pharmaceuticals, Matrizyme, Merck, Novartis, Novo Nordisk A/C, Pfizer, Regeneron, Sanofi, Servier, Tenax Therapeutics, Heart and Stroke Foundation of Ontario/University of Toronto, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Duke Clinical Research Institute, PERFUSE. Aronson: Employee of Bristol Myers Squibb. Windecker: Institutional research and educational grants from Abbott, Amgen, Bayer, BMS, CSL Behring, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, Polares, Sinomed. Alexander: Research grants from Bristol Myers Squibb, Boehringer Ingelheim, AstraZeneca, CryoLife, CSL Behring, US Food and Drug Administration, National Institutes of Health, Sanofi, VoluMetrix; consulting fees from Pfizer, Bristol Myers Squibb, AbbVie Pharmaceuticals, CSL Behring, Novo Nordisk, Portola Pharmaceuticals, Quantum Genomics, Teikoku Pharmaceuticals, VA Cooperative Studies, Zafgen. Lopes: Research grants from Bristol Myers Squibb, Pfizer, Amgen, Inc, GlaxoSmithKline, Medtronic PLC, Sanofi Aventis; consulting fees from Bristol Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer AG. The other authors report no conflicts.

The 9th Annual Clinical Trial Supply East Asia 2024 and 9th Annual Outsourcing in Clinical Trials East Asia 2024 will be held on December 3-4 in Seoul, focusing on clinical trial operations and regional pharmaceutical business in Asia. Key sessions include discussions on vaccine development, supply chain management, AI in drug discovery, and biosimilars, culminating in a WHO guidance session on clinical trial design and implementation.

GSK's GLISTEN trial shows linerixibat, an IBAT inhibitor, significantly reduces itch in PBC patients over 24 weeks vs. placebo, potentially becoming the first global therapy for PBC itch. PBC, a rare autoimmune liver disease, affects 510,000 globally by 2030, with 240,000 experiencing relentless itch. Current therapies are inadequate, highlighting a significant unmet need.

Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone (BorDex) significantly reduced the risk of death in the DREAMM-7 phase III trial for relapsed/refractory multiple myeloma compared to daratumumab plus BorDex, showing a statistically significant and clinically meaningful overall survival benefit.

Pharma leaders discussed clinical trial quality at SCOPE Europe, emphasizing the shift from reactive to proactive, risk-based approaches. Challenges include cultural resistance and high implementation costs, highlighting the need for senior leadership support and data-driven decision-making to ensure quality and efficiency in clinical trials.

Echo IQ (ASX:EIQ) signed an integration agreement with top US cardiology hospital Beth Israel Deaconess Medical Center, leveraging its FDA-cleared AI-powered algorithm for heart disease detection. This deal, following FDA clearance, positions EIQ for significant industry exposure and potential revenue generation, with further hospital partnerships anticipated. EIQ's technology targets aortic stenosis and heart failure, with reimbursement from insurance companies forming its revenue model. The company is also in advanced negotiations with the prestigious Mayo Clinic for clinical validation of its heart failure product.

GSK announces positive Phase III results for linerixibat in treating cholestatic pruritus associated with PBC, showing significant itch reduction over 24 weeks versus placebo. Linerixibat, an IBAT inhibitor, targets the root cause of itch in PBC, a rare autoimmune liver disease affecting women, with no current cure.