- Positive clinical trial results
- US regulator accepts review for new indications
- Asthma affects 26m people in US
GSK (GSK) announced positive results from a late-stage clinical trial to test the effectiveness and safety of depemokimab, an antibody used for treating patients with chronic rhinosinusitis with nasal polyps.
Twice yearly administration of depemokimab showed clinically meaningful and statistically ‘significant’ improvements in nasal polyp size and nasal obstruction, two key clinical measures of the disease’s severity.
GSK shares were up 1% to £14.83 in morning trading and have gained 9% year to date, around one percentage point ahead of the FTSE 100 index.
US REGULATORY REVIEW
In a separate statement GSK said the US FDA (Food and Drug Administration) has accepted for review the Biologics License Application for the use of depemokimab in two further indications.
The proposed indications are as an add-on maintenance treatment of asthma in adult and paediatric patients aged 12 and over with type two inflammation, and an add-on treatment in adult patients with inadequately controlled rhinosinusitis with nasal polyps.
Kaivan Khavandi, global head of respiratory, inflammation and immunology research and development at GSK said: ‘Simultaneous regulatory submissions for two indications highlight our confidence in depemokimab to help reduce the burden of both asthma and chronic rhinosinusitis with nasal polyps or patients and health systems.
‘Our SWIFT and ANCHOR trials support depemokimab's potential to suppress interleukin-5 (a protein), a known driver of type 2 inflammation, to offer patients sustained inhibition of a key driver of their disease with just two doses per year.’
The company said there are more than 26 million people in the US currently affected by asthma, leading to 100,000 hospitalisations and nearly one million emergency department visits each year.
‘We are determined to help reduce the burden that respiratory diseases like asthma and chronic rhinosinusitis with nasal polyps exert on patients and healthcare systems,’ said GSK.
People with the disease experience symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being.
