Clinical-stage biopharmaceutical company, Verona, has announced more positive news from its phase 3 ENHANCE-2 clinical trial of ensifentrine that treats chronic obstructive pulmonary disease (COPD).
The company focuses on respiratory diseases, and made the announcement today (October 14) about the positive analyses demonstrating how ensifentrine reduced exacerbation rates across subgroups in the trial.
Ensifentrine is a product candidate that combines bronchodilator and anti-inflammatory activities in one compound. Results of the subgroup analyses confirmed positive effects consistent with the exacerbation reduction observed in the overall population across all subgroups analyzed over 24 weeks. ENHANCE-2 was not powered for exacerbation rate in subgroups.
Previously reported in the overall population, ensifentrine demonstrated a 42% reduction in the rate of moderate to severe exacerbations over 24 weeks compared to those receiving placebo.
Verona says the market for COPD treatments is large with significant unmet medical need and the COPD disease burden in the US exceeds $50 billion in direct and indirect costs, with current maintenance treatments generating $ 10 billion in sales per annum but leaving more than 1 million patients symptomatic following maximum therapy.
An exacerbation was defined as a worsening of symptoms two major or one major and one minor requiring minimum of three days treatment with oral/systemic steroids and/or antibiotics or hospitalization.
Background medication included either a long-acting muscarinic antagonist (LAMA) or a long-acting beta-agonist (LABA). Approximately 15% of subjects also received inhaled corticosteroids (ICS).
“We are very encouraged by the meaningful and consistent reductions in rates of COPD exacerbations across all subgroups analyzed,” said David Zaccardelli, president and chief executive officer.
“Despite treatment with available therapies, many COPD patients continue to experience exacerbations, which are estimated to cause approximately 1.9 million emergency department visits and 740,000 hospitalizations per year in the United States alone.
“Pending assessment of the results from our ongoing phase 3 trial, ENHANCE-1, which is on track to read out around the end of 2022, these exacerbation data will be included in the New Drug Application in the U.S., which we expect to submit in the first half of 2023.”
Ensifentrine is an investigational, first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3 and PDE4) that combines bronchodilator and anti-inflammatory activities in one compound.
In phase 2 clinical studies in COPD, ensifentrine has shown significant and clinically meaningful improvements in lung function, symptoms and quality of life as a monotherapy or added onto a maintenance bronchodilator.
In the phase 3 ENHANCE-2 clinical trial, ensifentrine showed significant and clinically meaningful improvements in lung function measures and reduced the rate of COPD exacerbations. Ensifentrine has been well tolerated in clinical trials involving more than 2,200 subjects to date.
The two studies (ENHANCE-1 and ENHANCE-2) evaluate the efficacy and safety of nebulized ensifentrine as monotherapy and added onto a single bronchodilator, either a LAMA or a LABA, compared to placebo, and up to approximately 20% of subjects may receive ICS.
Upcoming milestones include top-line data from a second phase 3 trial, ENHANCE-1, in COPD around the end of this year(2022). A new drug application for the maintenance treatment of COPD will be submitted in the first half of 2023.