Dive Brief:
- Drugmaker GSK shared positive results Monday from two Phase 3 trials testing its inflammatory disease drug depemokimab in people with a condition known as chronic rhinosinusitis with nasal polyps.
- Earlier this year, the company said the same drug was successful in late-stage testing of adults and teenagers with asthma. Data from trials in both indications will be used for regulatory approval applications.
- GSK is also studying depemokimab in two other inflammatory diseases. GSK has set high expectations for the drug, predicting that, if approved, it could bring in over 3 billion pounds in peak annual sales.
Dive Insight:
Chronic rhinosinusitis with nasal polyps has caught the attention of drugmakers since U.S. approval of Sanofi and Regeneron Pharmaceuticals’ Dupixent in 2019.
Abbreviated as CRSwNP, the condition involves tissue growth in the nasal lining known as polyps and can cause a range of disruptive symptoms including sinus pain, loss of smell and sleep disturbance. According to GSK, as much as 4% of the general population is affected by the condition, which can be associated with asthma and allergic rhinitis.
Dupixent, which has become one of the pharmaceutical industry’s top-selling drugs, was approved as an add-on maintenance treatment for CRSwNP. It’s given every other week for that use, whereas GSK’s antibody is meant to be administered once every six months.
GSK tested its drug in two Phase 3 trials called Anchor-1 and Anchor-2, which together enrolled over 500 people and compared depemokimab to placebo over one year.
The company said treatment suppressed nasal polyp growth and eased nasal obstruction by significantly more than placebo. Treatment-emergent adverse events were similar between the two groups.
“Globally millions of people suffer from uncontrolled CRSwNP, the majority of whom will exhibit markers of Type 2 inflammation. These patients have high corticosteroid exposure and often experience recurrence of nasal polyps following surgery,” said Kaivan Khavandi, GSK’s global head of respiratory and immunology R&D, in a statement.
GSK will present detailed results from the trials at an upcoming scientific congress.
Depemokimab targets a protein called IL-5 that’s found at high levels in nasal polyps and is thought to drive Type 2 inflammation.
