Verona's ensifentrine a 'paradigm shift' in COPD treatment

After over a decade without progress in treating chronic obstructive pulmonary disorder (COPD), there is now potential for significant advancements from Verona Pharmaceuticals and the collaboration between Sanofi and Regeneron. Both companies are on the cusp of receiving FDA approval for their respective treatments, ensifentrine and Dupixent, later this June.

Sanofi and Regeneron’s drug, Dupixent, has drawn considerable attention as it nears FDA approval to become the first biologic treatment for COPD. The FDA’s decision is expected on June 27. Dupixent, already a megablockbuster, could set a new precedent in COPD care if approved.

On the other hand, Verona Pharmaceuticals, headquartered in London, is also poised for a pivotal FDA decision on June 26 for its COPD treatment, ensifentrine. Despite flying under the radar compared to Dupixent, ensifentrine has received favorable evaluations from industry experts, hinting at its potential to outshine its competitor.

Verona Pharmaceuticals presented compelling data on ensifentrine earlier this month at the American Thoracic Society (ATS) international conference. GlobalData, a leading analytics firm, heralded ensifentrine as a “paradigm shift in COPD treatment.” Key opinion leaders (KOLs) interviewed by GlobalData expressed positive views on the drug, citing its familiar nebulized form as an advantage for COPD patients over biologics.

KOLs also highlighted their enthusiasm for ensifentrine as a first-in-class medication. One expert emphasized the importance of novel treatment targets in advancing COPD care. Additionally, the Institute for Clinical Economic Review (ICER) suggested that ensifentrine would be cost-effective at an annual price between $7,500 and $12,700. ICER's chief medical officer, Dr. David Rind, commented that while ensifentrine has shown promise in combination with existing inhaled therapies, uncertainties remain regarding its efficacy with unstudied combinations.

Ensifentrine stands out due to its dual inhibition of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, combining bronchodilator and non-steroidal anti-inflammatory effects. Verona’s CEO, David Zaccardelli, emphasized that it represents the first novel inhaled COPD treatment mechanism in over two decades.

If approved, Verona plans to launch ensifentrine in the third quarter of this year. The company has not yet disclosed the treatment’s price. GlobalData projects that ensifentrine’s sales could reach $1.05 billion by 2029. This approval would mark the first commercial product for Verona Pharmaceuticals, a company founded 19 years ago to explore ensifentrine’s potential in treating COPD and other respiratory conditions.

Verona’s forthcoming launch has enabled the company to secure up to $650 million in financing, adding to its existing $255 million cash reserve as of the end of the first quarter. Zaccardelli noted that this financial runway extends beyond 2026.

Conversely, Dupixent's approval might face delays. Regeneron disclosed that the FDA has requested additional data from two trials, crucial for securing approval in its seventh indication. 

In summary, the imminent FDA decisions on ensifentrine and Dupixent could herald new, transformative treatments for COPD, offering hope to millions of patients and marking significant milestones for Verona Pharmaceuticals and Sanofi-Regeneron.

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