Oxford, U.K.-based Circassia Pharmaceuticals PLC said a phase 4 trial of Tudorza in certain patients with chronic obstructive pulmonary disease, or COPD, met its main goals.
The study, called Ascent, evaluated the long-term effect of Tudorza in about 3,600 patients with moderate to very severe COPD and heart disease or heart risk factors.
The trial met both main goals — the drug effectively reduced exacerbations, or worsening of disease, with no increase in heart-related adverse events, the company said. The therapy reduced the rate of moderate to severe COPD exacerbations by 22% compared to placebo during the first year of treatment. Further, Tudorza and placebo both showed similar time to a first major cardiovascular event.
Tudorza also reduced hospitalizations due to COPD exacerbations by 35% compared to placebo — a secondary goal of the trial.
Heart disease commonly occurs in people with COPD, a progressive lung disease, with about 30% of COPD patients dying from heart conditions, Circassia said.
Circassia plans to submit a supplemental new drug application for Tudorza in the coming weeks to include data from the Ascent trial in the drug's prescribing information.
AstraZeneca PLC sold the U.S. commercialization rights to its respiratory drugs Tudorza and Duaklir to Circassia in 2017.
