GSK's Studies on Depemokimab for Nasal Polyps Meet Primary Goals

GSK plc GSK announced positive data from the phase III ANCHOR-1 and ANCHOR-2 studies, which evaluated its pipeline candidate, depemokimab, for treating adults with chronic rhinosinusitis with nasal polyps (CRSwNP).

The studies evaluated the safety and efficacy of depemokimab versus placebo in adults with CRSwNP, a chronic condition affecting millions globally. The study's co-primary endpoints were to see the change from baseline in total endoscopic nasal polyp score at 52 weeks and the change from baseline in mean nasal obstruction score from weeks 49 to 52.

Data from the studies showed that treatment with depemokimab led to a statistically significant reduction in nasal polyp size and nasal obstruction compared to placebo plus standard of care at 52 weeks, thereby meeting the co-primary endpoints.

Depemokimab is an inhibitor of IL-5, which is a key cytokine (protein) in type II inflammation. IL-5 is present at high levels in nasal polyp tissue.  IL-5 inhibitors play a key role in reducing type II inflammation.

Year to date, shares of GSK have risen 5.5% against the industry’s decline of 2.1%.

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Type II inflammation is responsible for CRSwNP experienced by more than 80% of patients with this condition. Depemokimab is designed in such a way that it targets and suppresses a key inflammatory pathway underlying nasal polyp growth and nasal obstruction.

The full results from the ANCHOR-1 and ANCHOR-2 studies will be presented at an upcoming scientific conference.

More on GSK's Depemokimab Development Plans

Earlier this year, two phase III studies namely — SWIFT-1 and SWIFT-2 — which evaluated depemokimab for treating severe asthma characterized by type II inflammation met their primary endpoints.

Data from the SWIFT-1 and SWIFT-2 studies showed that treatment with depemokimab resulted in statistically significant and clinically meaningful reductions in exacerbations (asthma attacks) over 52 weeks versus placebo.

The positive data from the SWIFT-1 and SWIFT-2 studies along with the latest data from the ANCHOR-1 and ANCHOR-2 studies will support global regulatory filings for depemokimab.

Depemokimab is currently not approved for any indication. Depemokimab is also being evaluated in late-stage studies for eosinophilic granulomatosis with polyangiitis and hyper-eosinophilic syndrome.

GSK's Respiratory Portfolio

Sales in GSK’s respiratory portfolio are currently being driven by its blockbuster anti-IL5 biologic, Nucala. The drug is approved in several countries for treating eosinophil-driven diseases like severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.

Nucala is administered once every four weeks by a subcutaneous injection.

Sales of Nucala increased 15% at a constant exchange rate in the first half of 2024 to £856, driven by strong patient demand globally. GSK is also working on expanding the label of Nucala for treating chronic obstructive pulmonary disease (COPD) currently in phase III evaluation.

Other Players in the Respiratory Diseases Market

Sanofi SNY and Regeneron’s REGN blockbuster medicine, Dupixent, an IL-4 and IL-13 inhibitor, is currently approved in several countries, including the United States and EU, for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.

Last month, the FDA approved Dupixent as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype, marking the sixth approved indication for the drug.

SNY/REGN’s Dupixent was approved for treating COPD in patients with raised blood eosinophils in the EU in July.

Besides Dupixent, Nucala faces strong competition from AstraZeneca’s AZN Fasenra, also an IL-5 inhibitor.

Fasenra is approved for treating severe eosinophilic asthma. AZN is also evaluating Fasenra in late-stage studies for treating nasal polyps and COPD among others.

Last month, the FDA approved Fasenra for treating eosinophilic granulomatosis with polyangiitis.

GSK's Zacks Rank

GSK has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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