GSK Accelerates Late-Stage Studies as It Targets COPD and Long-Acting Respiratory Treatments

Key Points

• GSK plans to accelerate six Phase III study starts for its long-acting TSLP treatment felcorekibart across asthma, nasal polyps and COPD, after encouraging Phase II results. The company expects to share the data next year; the treatment’s efficacy in COPD remains unproven.
• GSK is advancing an IL-33 treatment toward potential Phase III COPD studies next year and has started a study combining it with its TSLP medicine to test for added benefit.
• The company is also progressing late-stage plans in food allergy and studying gatuzosiran for alcohol-related liver disease, where Phase II results could help shape future development.

GSK NYSE: GSK is advancing a portfolio of long-acting medicines and combination treatments for respiratory and inflammatory diseases, with a particular focus on chronic obstructive pulmonary disease, a senior research executive said at Guggenheim’s Healthcare Innovation Conference.

Kaivan Khavandi, GSK’s senior vice president of R&D and head of respiratory, immunology and inflammation, described COPD as an underappreciated opportunity where targeted therapies remain in their early stages. He also discussed planned late-stage studies in asthma, nasal polyps and food allergy, as well as research into alcohol-related liver disease.

Khavandi said GSK’s research approach starts with questions about which patients might respond to a treatment and how a proof-of-concept study would be designed. Identifying a biomarker for a responder population can be more important to a program’s progress than conducting years of additional biology research, he said.

Long-acting respiratory treatments

GSK is pursuing longer-acting medicines in part to help patients remain on treatment, Khavandi said. In asthma, he described the approach as “pragmatic innovation,” arguing that sustained use can help patients maintain the benefits measured in clinical trials and potentially achieve remission.

Khavandi said early results from the Phase II NAZARE study of felcorekibart, GSK’s long-acting TSLP treatment, were encouraging enough to accelerate six planned pivotal Phase III study starts across asthma, chronic rhinosinusitis with nasal polyps and COPD. The company expects to share the data next year, he said.

GSK selected a single dose for the three airway indications, drawing on Phase II data in asthma and nasal polyps and modeling for COPD, Khavandi said. He expressed confidence that felcorekibart could be administered twice yearly, while noting that the efficacy of the TSLP mechanism in COPD has not yet been proven.

IL-33 and combination studies

GSK is also developing an IL-33 treatment for COPD and non-cystic fibrosis bronchiectasis, a disease characterized by airway damage and mucus buildup. Khavandi said the company had begun discussions with regulators about starting Phase III COPD studies next year, including a planned cardiopulmonary outcomes study.

Phase II results in non-CF bronchiectasis are expected by the end of next year, he said. Khavandi cautioned that evidence about IL-33’s effects remains debatable, but said observations around mucus plugging and inflammation helped support testing the mechanism in bronchiectasis.

GSK has also recently started a COPD study combining its separate TSLP and IL-33 medicines. Khavandi said the goal is to determine whether the combination provides an additive or synergistic benefit. If successful, the findings could support advancing a single bispecific treatment targeting both mechanisms into late-stage development.

Food allergy and liver disease

In food allergy, GSK is studying ozureprubart, a long-acting antibody that Khavandi said is designed for dosing every three months. The company expects to evaluate Phase II results next year and hopes to start pivotal programs in both food allergy and spontaneous urticaria, he said.

Khavandi also highlighted a Phase II study of gatuzosiran in alcohol-related liver disease. The treatment targets HSD17B13, which he described as a genetically supported but novel target that brings development risk.

The study could inform a potential Phase III program for gatuzosiran, the development of GSK’s efimosfermin in the same disease, or a combination of the two, Khavandi said. Efimosfermin is also in Phase III development elsewhere in GSK’s portfolio.

About GSK (NYSE:GSK)

GSK plc is a global biopharmaceutical company headquartered in the United Kingdom. It researches, develops and manufactures medicines and vaccines, with a focus on areas including infectious diseases, HIV, respiratory and immune conditions, and cancer.

Its products include vaccines such as Shingrix, which helps prevent shingles, and Arexvy, for respiratory syncytial virus (RSV). GSK also makes specialty medicines, including treatments for HIV and respiratory diseases, and continues to develop new medicines and vaccines through its research programs.

The company was formed in 2000 through the merger of Glaxo Wellcome and SmithKline Beecham, businesses with histories stretching back much further.

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