After a year of remarkable achievements, Verona Pharma plc (VRNA) looks to make 2023 even more momentous.
Verona Pharma is a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs.
The lead drug candidate is Ensifentrine, which combines bronchodilator and anti-inflammatory properties in one compound, with the potential to be an effective treatment for chronic obstructive pulmonary disease and other respiratory diseases, including asthma and cystic fibrosis.
Ensifentrine, in nebulized formulation, has been studied in a phase III program for chronic obstructive pulmonary disease maintenance treatment, dubbed ENHANCE, comprising of two trials – ENHANCE-1 and ENHANCE-2.
The primary endpoint of the ENHANCE program was improvement in lung function as measured by forced expiratory volume in one second (“FEV1”) over 12 hours with Ensifentrine after 12 weeks of treatment.
Results from the ENHANCE-2 trial, reported last August, showed that it successfully met the primary endpoint, as well as secondary endpoints, demonstrating improvements in lung function, besides significantly reducing the rate and risk of COPD exacerbations.
In the study, subjects receiving Ensifentrine demonstrated a 42% reduction in the rate of moderate to severe COPD exacerbations over 24 weeks compared to those receiving placebo.
Results from the ENHANCE-1 trial were reported last December. The study successfully met its primary and key secondary endpoints demonstrating significant improvements in lung function, symptoms and quality of life measures. There was a 36% reduction in rate of exacerbations over 24 weeks in the ENHANCE-1 trial.
Armed with the impressive results from the phase III ENHANCE program, Verona expects to submit a New Drug Application to the FDA in the second quarter of 2023 for inhaled Ensifentrine for the maintenance treatment of patients with COPD.
If approved, Ensifentrine has the potential to achieve blockbuster sales, according to analysts.
The company ended Dec.31, 2022, with cash and cash equivalents of $227.8 million.
VRNA was trading around $5.98 when it was featured on our site on Jul.19, 2022. The stock touched an all-time high of $26.44 on Jan.3, 2023. It has now given back some of its gains and trade around $20.
The stock has traded in a range of $3.41 to $26.44 in the last 1 year. VRNA closed Friday’s trading at $20.63, up 3.93%.
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