Verona Pharma, a clinical-stage biopharmaceutical company, is progressing with its new COPD treatment, ensifentrine, which shows promise in addressing significant unmet needs in the COPD market. In this regard, the company presented an abstract on Inhaled Ensifentrine, decreased healthcare research utilization, and reduced moderate exacerbation rate and risk in COPD over 24 weeks at the International Congress of the European Respiratory Society (ERS) 2023 from 9 to September 13 in Milan, Italy.

Needless to say, COPD is devastating; the condition causes a gradual blockage of airflow in and out of the lungs, resulting in an increasingly arduous breathing process. The symptoms include breathlessness, persistent cough, wheezing, and chest tightness. The analysts at DelveInsight have deep-dived their understanding in “Chronic Obstructive Pulmonary Disease (COPD) - Market Insight, Epidemiology and Market Forecast – 2032” estimating that there were 35.6 million diagnosed prevalent cases in the 7MM (the US, EU4 countries (Germany, France, Italy, Spain) and the UK, and Japan) in 2022 wherein the US comprised of 18 million cases in the same year.

The current COPD treatment is restricted to only three MoAs encompassing LAMA, LABA, and ICS to combat this prevalent and life-threatening lung condition without a cure. Adding to the treatment build-up, ensifentrine, Verona’s flagship product, uniquely combines a long-acting muscarinic antagonist and a phosphodiesterase-4 inhibitor to improve lung function and reduce COPD exacerbations. Recognition of its new mechanism of targeting airway smooth muscle and inflammatory cells, ensifentrine offers a potential therapeutic breakthrough for people who have not responded to standard treatments approved for decades. As a selective dual-inhaled inhibitor of PDE3 and PDE4, ensifentrine is being developed as a “first-in-class” maintenance treatment for COPD. Ensifentrine is also being studied as a potential treatment for other indications. However, Verona primarily focuses on the approval and rollout to treat COPD.

COPD treatment is a competitive field with established players and treatments, which can pose market penetration challenges. Given the size of the COPD market and limited effective treatment options, the potential for Ensifentrine to transform the treatment paradigm is significant, putting Verona in the spotlight.

Under clinical development, Ensifentrine underwent a randomized, double-blind, placebo-controlled ENHANCE-1 trial (NCT04535986) with moderate to severe symptomatic COPD. According to the results of the trial, the primary endpoint was met. At Week 24, the ensifentrine group had fewer unscheduled visits to the doctor’s office (6.5% vs. 10.6%) and emergency room visits resulting in hospitalization (3.6% vs. 4%, 9%) compared to the placebo group. Ensifentrine reduced the rate of moderate/severe exacerbations (36%) and the immediate risk, assessed by time to first exacerbation (38%) compared to placebo. Improvement in lung function was determined based on the primary endpoint of FEV estimation as well as several additional secondary endpoints. Verona Pharma advanced towards submitting a New Drug Application (NDA) in June 2023.

Results from the ENHANCE program showed significant and clinically meaningful improvements in the function of the lungs, along with substantial reductions in the rate and risk of exacerbations. This highlights the potential of Ensifentrine to not only relieve symptoms but also impact disease progression, a significant unmet need in the COPD field.

Based on DelveInsight’s analysis, the COPD market in 2022 was estimated to be USD 12.5 billion in the 7MM, which is likely to surge with a considerable CAGR in the forecast period. Given the size of the COPD market and the limited effective treatment options, every coming treatment is crucial to transform the treatment paradigm. If approved, Ensifentrine would be the first new treatment with a unique mechanism of action to come to market for COPD in more than a decade, presenting a massive opportunity for market penetration and growth as to its added worth, Ensifentrine can carve out a significant niche in the COPD market due to its innovative nature.

The main value proposition of Ensifentrine is that it has a novel mechanism that may provide additional treatment options for bronchodilator and steroid-resistant patients. Ensifentrine could become a blockbuster drug and a good addition to prescribers’ arsenal in treating COPD, as many patients swap around different combinations as the disease progresses.