BTG has announced the successful outcome of the RENEW study, the pivotal US randomised controlled clinical trial comparing the safety and efficacy of the PneumRx endobronchial coil implant with a medical therapy control group in patients with homogeneous and/or heterogeneous severe emphysema. All primary and secondary endpoints of the study were met.
Patients treated with PneumRx showed a statistically significant 10.2 metre benefit vs. control patients in change in the six-minute walk test at 12 months, which was the study primary endpoint (p=0.0153).
PneumRx is a shape-memory nitinol coil implanted in the sub-segmental airways of the lung in patients with severe emphysema via a minimally invasive bronchoscopic procedure.
Importantly, patients treated with the PneumRx exhibited statistically significant and clinically meaningful improvements vs. control patients at 12 months in quality of life measured by Saint George Respiratory Questionnaire (SGRQ) (mean improvement of 8.9 points over the control group, p<0.0001) and lung function measured by Forced Expiratory Volume in one second (FEV1) (mean litres per cent improvement of 8.8% over the control group, p<0.0001).
Serious adverse events in the treatment and control groups were as expected in a patient population of mostly GOLD IV patients (GOLD is short for the Global Initiative for Chronic Obstructive Lung Disease, a collaboration between the National Institutes of Health and the World Health Organization. The GOLD staging system classifies people with chronic obstructive pulmonary disease (COPD) based on their degree of airflow limitation (obstruction). Events associated with bronchoscopy and endobronchial coil implant placement such as pneumothorax, lower respiratory tract infections, respiratory failure, haemoptysis, COPD exacerbation, and dyspnoea occurred, as anticipated, at a higher rate in the treatment arm.
Louise Makin, BTG’s CEO, commented: “We are delighted with the successful outcome of RENEW, showing significant benefit in patients treated with the PneumRx coils in one of the largest randomised controlled clinical trials of a medical device in patients with severe emphysema to date incorporating both patient reported and objective outcomes. We will now progress our regulatory application in the US, which we anticipate submitting around mid-2016.”
RENEW included 315 patients who were randomised to receive treatment with PneumRx or standard of care medical therapy. The primary endpoint of the study was a mean absolute improvement from baseline at 12 months in the six-minute walking test. The secondary endpoints included a responder analysis for this test, FEV1 mean pe rcent change measured using spirometry and SGRQ mean absolute difference. Detailed analysis of the data continues, with full data expected to be submitted to a peer-reviewed journal for publication in due course.