GSK’s Nucala passed a late-phase test in chronic obstructive pulmonary disorder, setting the stage for a showdown against a new group of contenders that is looking to refresh the treatment paradigm for the lung disease.
Nucala is currently approved for a range of respiratory conditions, including severe asthma and chronic rhinosinusitis. But a label expansion to COPD could open a much bigger market opportunity, with more than 300 million people diagnosed globally, according to GSK.
In the placebo-controlled Phase 3 MATINEE trial primary endpoint, the anti-IL-5 monoclonal antibody plus inhaled maintenance therapy attained a statistically significant reduction in the yearly rate of moderate or severe exacerbations in COPD patients at up to 104 weeks. The study enrolled subjects who had two or more moderate exacerbations or at least one severe exacerbation in the 12 months prior to screening, in addition to evidence of type 2 inflammation, which was measured by raised blood eosinophil count.
GSK did not publish any figures, but it plans to detail them at an upcoming scientific meeting and share them with regulatory agencies as part of ongoing engagement, according to a release on Friday.
Last month, TD Cowen analysts said the bar for success in COPD had been set by Sanofi and Regeneron’s dual IL-4/IL-13 blocker Dupixent. In the Phase 3 NOTUS trial, Dupixent plus standard of care slashed exacerbations by 34% versus placebo. The FDA is due to decide whether to approve the drug by Sept. 27 following a three-month extension to the original PDUFA date.
As for Nucala, the monoclonal antibody won its first FDA approval in 2015 for severe asthma. It has since secured label expansions for chronic rhinosinusitis and hypereosinophilic syndrome, among other indications. Nucala’s sales were up 17% in the second quarter to £482 million ($634.7 million), compared to the same period in 2023.
If Nucala is approved for COPD, it won’t be the only new option. In June, the FDA greenlit Verona Pharma’s ensifentrine, marking the first new maintenance treatment for COPD with a novel mechanism in more than two decades. Ensifentrine targets the PDE3 and PDE4 enzymes.
Elsewhere, AstraZeneca and Amgen are also investigating their TSLP-targeting monoclonal antibody Tezspire for COPD. Earlier in the pipeline, Uniquity Bio is working on a former Merck candidate dubbed solrikitug, which it recently advanced to Phase 2 development.