New wave of potential therapies will bring shift in treatment paradigm for COPD

London: The recent submission of clinical trial data for Sanofi/Regeneron’s Dupixent and Verona’s Ensifentrine to the Food and Drug Administration (FDA) indicates the entry of new therapies for chronic obstructive pulmonary disease (COPD) in 2024. Both Phase III pipeline agents were able to meet their trial endpoints and are to be used as maintenance or add-on therapies to the standard of care. This new wave of potential therapies will bring a shift in the treatment paradigm for COPD, according to GlobalData.

GlobalData’s Sales and Forecast database projects total sales for Dupixent to reach $21.4 billion globally by 2029, and ensifentrine is forecast to record sales of $1.1 billion by 2029.

Asiyah Nawab, Pharma Analyst, GlobalData, commented, "The standard of care (SoC) when treating COPD patients involves the use of either short- or long-acting beta-2 agonists or muscarinic antagonist as a monotherapy, or in combination. Alternatively, for exacerbators, the addition of inhaled corticosteroids (ICS) as a triple therapy regimen or taken alongside a long-acting beta agonist as a fixed-dose combination. Phosphodiesterase inhibitors (PDE) can be used as an add-on to triple therapy, depending on the severity of COPD. These therapies are tolerable by patients; however, the progressive nature of COPD has created a need for additional maintenance therapy alongside the SoC."

The current gap in the COPD market is the absence of biologics. However, Sanofi/Regeneron’s Dupixent, an interleukin-4 and interleukin-13 inhibitor, has the potential to address this gap, as positive results were reported from two Phase III clinical trials, BOREAS and NOTUS, and in both trials, the primary endpoint of the trials was met.

Nawab continued, "The trials show that Dupixent significantly reduced moderate or severe acute COPD exacerbations by 30 per cent in the BOREAS trial and 34 per cent in the NOTUS trial over 52 weeks, and improved lung function at 12 weeks that was sustained through 52 weeks, compared to placebo. The positive results from both clinical trials led to FDA acceptance of Sanofi/Regeneron’s supplemental Biologics License Application (sBLA) as an add-on maintenance therapy and have set an FDA decision date for June 27, 2024. Key opinion leaders (KOLs) interviewed by GlobalData have expressed that Dupixent’s two trial endpoints are positive and would be surprised if there was a pushback in the FDA decision."

As for Verona’s Ensifentrine, a first-in-class dual PDE3/4 inhibitor administered as a nebulised formulation, has also gained the FDA’s interest after two positive phase III trials (ENHANCE-1 and ENHANCE-2) met their primary endpoint of reducing exacerbations and improving lung function.

Nawab concluded, "The COPD late-stage market looks extremely promising, representing a shift in the treatment paradigm for COPD. The introduction of biologics and a novel ‘first-in-class’ dual phosphodiesterase inhibitor, given their positive clinical trial data, may lead to their penetration into the market this year. KOLs interviewed by GlobalData have expressed that the pipeline for COPD is extremely positive, with Sanofi/Regeneron’s Dupixent and Verona’s Ensifentrine having a high chance of being licensed, and that the COPD space has not been in this position for decades."