Verona’s COPD Candidate Scores Clinical Win, Paving the Way for FDA Submission

United Kingdom-based Verona Pharma announced that its lead candidate, ensifentrine, met its primary and secondary endpoints in the first of two Phase 3 trials. The clinical success of the chronic obstructive pulmonary disease (COPD) drug nearly doubled Verona’s stock price overnight. The outcome sets the stage for the next clinical trial results, which would be the basis for a New Drug Application (NDA) sometime in the first half of next year. 

Ensifentrine’s Performance in the ENHANCE-2 Trials

COPD is a chronic inflammatory lung condition that can block airflow to the lungs, making it difficult to breathe. Several available treatment options often use a combination of therapies that act as anti-inflammatory and bronchodilator medicines separately. Verona says it designed ensifentrine as an anti-inflammatory and bronchodilator in one compound, reducing inflammation and opening airflow in one fell swoop. 

The ENHANCE-2 Phase 3 trial studied a population of about 800 participants, 52% of which received background therapy of either long-acting muscarinic antagonist or long-acting beta-antagonist. On top of that, about 15% of participants took inhaled corticosteroids with the previously mentioned background therapies. 

For 24 weeks, the participants received two daily doses of either ensifentrine or placebo through a nebulizer. They tested their lung strength through the standardized forced expiratory volume (FEV1) test, which measures how much air a patient can forcefully exhale in one second. At 12 weeks, placebo-corrected results demonstrated a change from baseline lung function of 94mL, satisfying the study’s primary endpoints. 

Ensifentrine also met secondary endpoints by demonstrating a placebo-corrected peak FEV1 of 146mL and an increase in the morning trough FEV1 of 49mL. The trial also demonstrated a 42% reduction in exacerbation rates among those who took ensifentrine compared to the placebo. 

While the trial demonstrated positive results in the desired areas of primary and secondary endpoints, ensifentrine did not result in statistically significant differences in COPD symptoms and quality of life compared to placebo. 

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Ensifentrine’s Path Going Forward

With glowing results from ENHANCE-2 in the rearview, Verona can shift its focus to ENHANCE-1, which it hopes to report by the end of the year. Based on the upcoming results, Verona hopes to submit ensifentrine for FDA approval in the first half of 2023. 

If the drug receives approval, it would be Verona’s first commercialized product, hopefully proving the worth of the hundreds of millions invested in the company in recent years. Ensifentrine would be up against some tough competition, like GSK’s Advair, which brought in $587 million last year, and AstraZeneca’s newly-approved Breztri Aerosphere, which brought $203 million in its first full year of sales last year. 

Following the positive results from the ENHANCE-2 Phase 3 trials, Verona is in a good position to continue advancing ensifentrine through the development process. The drug would provide a unique anti-inflammatory and bronchodilator aspect that most other treatments can only accomplish with combination therapies. A potential approval could add another option for the millions suffering from COPD throughout America and potentially worldwide. 

Author

Reed Slater