GSK announced another batch of positive data from its respiratory program with the investigational drug depemokimab, this time in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
Both the Phase 3 ANCHOR-1 and ANCHOR-2 trials met the co-primary endpoints: the total endoscopic nasal polyp score at 52 weeks and mean nasal obstruction score from weeks 49 to 52. Treatment-emergent adverse events in the trials were similar in patients treated with either the drug or placebo, the UK-based company said, explaining its potential long-acting option can be dosed once every six months.
Kaivan KhavandiData from the trials will be used in regulatory filings globally, GSK’s SVP and global head of respiratory and immunology R&D Kaivan Khavandi said.
“These patients have high corticosteroid exposure and often experience recurrence of nasal polyps following surgery,” Khavandi said in a statement. He added that the data “demonstrate the potential for depemokimab to offer targeted and sustained suppression of a key inflammatory pathway underlying nasal polyp growth and nasal obstruction.”
CRSwNP is a chronic condition that is caused by inflammation of the nasal lining and can lead to nasal polyps, along with other symptoms like loss of smell and pressure in the face. It affects up to 4% of the general population, and executives have said that if depemokimab, which targets interleukin-5 (IL-5), is approved, they expect it to reach £3 billion ($3.9 billion) in peak annual sales.
This is the second batch of data from trials with depemokimab in as many months: In September, GSK released data showing that depemokimab reduced asthma attacks by 54% in two large Phase 3 trials, though the studies did miss statistical significance on secondary endpoints assessing quality-of-life and symptom-based measures.