GSK posts results for 2021 COVID-19 SAM vaccine trial; advances four Phase 3 respiratory studies

This week's GSK activity spanned a completed early-stage vaccine trial and new movement across several later-stage respiratory, liver, and infectious disease studies.

• GSK posted results for NCT04758962, a completed Phase 1 first-in-human trial of a self-amplifying mRNA lipid nanoparticle COVID-19 vaccine. The study gave 10 participants two 1-microgram doses of the CoV-2 SAM (LNP) vaccine, one at Day 1 and one at Day 31¹, with results first posted 2026-08-24.
• "PERSIST ASTHMA-2" (NCT07782996), a Phase 3 trial of felcorekibart (GSK5784283) as add-on therapy in uncontrolled asthma, is not yet recruiting. The trial plans to enroll 370 participants and its primary outcome is the annualized rate of clinically significant asthma exacerbations, defined as worsening asthma symptoms requiring systemic corticosteroids or hospitalization of at least 24 hours².
• "PERSIST CRSwNP-2" (NCT07782957), a Phase 3 trial of felcorekibart in chronic rhinosinusitis with nasal polyps, is recruiting. The study plans 218 participants with a primary endpoint of change from baseline in total endoscopic nasal polyps score at Week 52^3,4.
• "PERSIST CRSwNP-1" (NCT07782970), a companion Phase 3 CRSwNP trial of felcorekibart, is not yet recruiting with an estimated enrollment of 218 and the same change from baseline in total endoscopic nasal polyps score at Week 52 primary outcome.
• "ALLSTAR" (NCT07791043), a Phase 2 dose-finding trial of efimosfermin alfa in alcohol-related liver disease, is recruiting. The study is a dose-ranging study to evaluate safety of efimosfermin alfa and to establish proof-of-concept that efimosfermin alfa therapy provides benefit in participants with ALD⁵, enrolling an estimated 274 participants.
• A Phase 1 drug-drug interaction study (NCT07784894) of ganfeborole (GSK3036656) for tuberculosis with the oral contraceptive Microgynon is not yet recruiting. The trial is designed to assess the pharmacokinetics, safety, and tolerability of Ganfeborole and Microgynon when Microgynon is administered alone and in combination with Ganfeborole in healthy female participants of non-childbearing potential⁶, enrolling an estimated 28 participants.
• A Phase 1 pharmacokinetics study (NCT07789899) comparing two formulations of investigational GSK3862995B in healthy participants is recruiting. The trial plans to enroll 24 participants and aims to assess how the body absorbs and processes the medicine, and to evaluate its safety and tolerability⁷.