Bioxyne Limited has confirmed that it is on track for the release of data from its Phase IIb trial as scheduled in June.
The Company confirmed the 320-patient study to evaluate the efficacy and safety of the Bioxyne’s HI-164OV therapy for patients with chronic obstructive pulmonary disease (COPD) had been closed and that data was in the late stages of analysis.
The primary aim of the study is to assess the impact of treatment with HI-164OV in reducing severe exacerbations in COPD patients and reducing the need for admission to hospital.
There are a number of measures of disease severity being examined which will define the profile and benefits of HI-164OV and its potential long term value.
Bioxyne Chief Executive Officer David Radford said, “We are focused on ensuring accurate communication of the trial results and to also guard against partial and incomplete reporting of the results.
“Given the importance of the results, Bioxyne may consider a short-term trading halt during the period between our receipt of initial data through until the time when the Company has formally assessed the final result and is able to accurately communicate these results to the market.
The primary endpoint in the trial is a demonstration of a reduction in exacerbations requiring oral corticosteroid treatment or hospitalization.
The secondary endpoints seek to determine if HI-164OV can reduce the severity of exacerbations, the number of patients experiencing exacerbations requiring corticosteroid treatment or hospitalization and a reduction in the use of antibiotics and or corticosteroids.
There have been no indications of patient related safety issues during the trial.