GSK is heading into the weekend with a win for its respiratory blockbuster Nucala—but for now, the details are slim.
On Friday, GSK said that its IL-5 antibody Nucala plus inhaled maintenance therapy lowered the annualized rate of moderate or severe exacerbations among chronic obstructive pulmonary disease (COPD) patients for up to 2 years.
In turn, the MATINEE trial, which pitted Nucala against placebo, met its primary endpoint, GSK said in a release.
While detailed data were not presented in GSK’s announcement, the British drugmaker said it plans to share the full results of the study at a future medical conference. GSK added that it will use those data to “inform ongoing discussions with regulatory authorities” about a potential Nucala label expansion.
Nucala made its debut in 2015 with an FDA approval for severe asthma. Since then, the antibody has racked up a series of respiratory nods, including for Churg-Strauss Syndrome, severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps.
Still, Nucala could be looking at a big opportunity in COPD, which GSK estimates affects more than 300 million people around the world. Up to 40% of those patients display type 2 inflammation marked by raised blood eosinophil count, which in turn drives disease exacerbations that can cause lung damage, progressive lung function decline and risk of hospitalization.
Since IL-5 is a key messenger protein in type 2 inflammation, GSK figures its respiratory stalwart could be a good fit for many of those patients.
GSK’s MATINEE trial—which is one of three testing Nucala in COPD—recruited patients with broad clinical presentations of chronic bronchitis and/or emphysema who were already being treated with inhaled maintenance therapy. Patients in the study also had to have evidence of type 2 inflammation marked by raised blood eosinophil count.
COPD prevents airflow to the lungs and causes breathing problems. The condition, which is a leading cause of death in the U.S., according to the CDC, is mainly caused by smoking, though nonsmokers are also susceptible.
Nucala is the crown jewel in GSK’s respiratory franchise and brought home 1.65 billion pounds sterling ($2.2 billion) for all of 2023. In 2024’s second quarter, the antibody generated 482 million pounds ($635.7 million), growing 17% at constant currencies over the sum it drew in during the same period last year.
GSK is rekindling its COPD bid for Nucala after the FDA rebuffed the drug in the condition back in 2018, echoing the opinions of an advisory panel that had previously questioned whether there were enough data to approve the antibody in patients with high eosinophil levels.
At the time, the setback marked the end of a long-running COPD race between Nucala and AstraZeneca’s own IL-5 antibody Fasenra. Earlier that same year, AZ disclosed that Fasenra had failed in a phase 3 trial—the second of two—in patients with moderate to very severe COPD.
The trial flopped halted Fasenra’s trajectory in COPD, though AZ has since had luck with other medications, such as the triple combination inhaled corticosteroid Breztri, which passed muster with the FDA as a COPD maintenance treatment in 2020.
Earlier this year, AZ and its partner Amgen reported mixed data on their asthma drug Tezspire in the condition. In the phase 2a COURSE study, Tezspire failed to meet its primary endpoint but did show the effectiveness of the antibody in certain patients with COPD.
As GSK builds the case for Nucala in COPD, one would-be rival—Sanofi and Regeneron’s Dupixent—recently hit a snag in the disease in the U.S.
In late May, the partners revealed that the FDA had pushed back its planned decision date for a potential Dupixent COPD approval to Sept. 27. The regulatory decision, while disappointing, wasn’t a complete surprise, as Regeneron said earlier that same month that the FDA had requested additional data from two trials positioning Dupixent for a potential label expansion in COPD.
The very same day Sanofi and Regeneron revealed their setback at the FDA, Europe’s drug regulator recommended Dupixent for approval to treat the respiratory illness.
Meanwhile, Verona Pharma in June received a thumbs up from the FDA for its COPD maintenance treatment Ohtuvayre (ensifentrine) in adults. At the time, Verona touted its drug—which inhibits the PDE3 and PDE4 enzymes—as the first inhaled COPD product with a novel mechanism of action for maintenance treatment in more than 20 years.
Verona added that it was “fully staffed to launch” and said it expects Ohtuvayre to hit the U.S. market in the third quarter through a network of specialty pharmacies.
Editor's note: This story has been updated with additional background on Nucala's development in COPD.