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Compilenewborn
According to FierceBiotech's report, GlaxoSmithKline (GSK) has decided to terminate the clinical development of the antibody drug otilimab for COVID-19
.
There are two reasons.
otilimab is a fully human monoclonal antibody that targets to bind to and inhibit granulocyte-macrophage colony stimulating factor (GM-CSF), a protein that plays a central role in a wide range of immune-mediated diseases (including RA)
.
otilimab neutralizes the biological functions of GM-CSF by blocking the interaction of GM-CSF with its cell surface receptors
In February of this year, GSK announced the results of the Phase 2 OSCAR clinical trial
.
The study included COVID-19 patients with severe COVID-19-related lung disease and requiring large amounts of oxygen support or early invasive mechanical ventilation
Encouraged by the signs of efficacy, GSK decided to modify the OSCAR study, enrolling an additional 350 elderly people in the cohort of 70 years and older to verify the role of otilimab in this population, and completed the study in the summer
.
Although GSK has not yet shared the data of the expanded cohort, the company has concluded that the continued evolution of the COVID-19 pandemic, and the overall progress of the company's COVID-19 project, does not support further research on otilimab in COVID-19
In the third-quarter financial report, GSK wrote: “There is increasing evidence that Xevudy (sotrovimab) plays an important role in the treatment of mild to moderate COVID-19 in high-risk adults and pediatric patients.
It continued to evolve and decided to generate more data about the drug
.
Therefore, it was decided not to further explore otilimab as a potential treatment for severe lung COVID-19-related diseases
Xevudy is a single-dose anti-SARS-CoV-2 monoclonal antibody developed by GSK and Vir Biotechnology.
It has been granted emergency use authorization in many countries (including the United States) for the treatment of SARS-CoV-2 virus test results Adults and adolescents (12 years and older, weight ≥40 kg) who are positive and are at high risk of developing severe COVID-19 (including hospitalization and death)
.
At the same time, Xevudy has signed a binding agreement to sell and supply more than 420,000 doses
Although GSK has decided to stop studying otilimab in COVID-19, the company is still investigating the drug to treat RA
.
Currently, Phase 3 clinical trials for this indication are continuing, and data is planned to be provided in the second half of next year
Reference source: GSK, after pushing past midphase fail, ends development of otilimab in COVID-19
