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Verona Pharma (NASDAQ:VRNA) on Friday reported additional exacerbation subgroup analyses from a phase 3 trial of ensifentrine to treat patients with chronic obstructive pulmonary disease (COPD).
The late-stage study called ENHANCE-2 — top-line results from which were presented in August — had met its main goal of improving lung function with significant reductions in rate and risk of COPD exacerbations, according to the London-based company
The study defined exacerbation 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.
The company said that results of the subgroup analyses confirmed positive effects consistent with exacerbation reduction seen in the overall population across all subgroups analyzed over 24 weeks.
Verona noted that as previously announced, in the overall study population (n=789), ensifentrine showed a 42% reduction in the rate of moderate to severe exacerbations over 24 weeks, compared to those on placebo.
The study was not powered for exacerbation rate in subgroups, according to the company.
“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 US, which we expect to submit in the first half of 2023,” said President and CEO David Zaccardelli.