ELEVATE study aims to improve selection criteria and outcomes for patients with severe emphysema treated with the PneumRx Endobronchial Coil System

London, UK, 11 June 2018

Recruitment begins in 7 European Countries

BTG plc (LSE: BTG), the global healthcare company, today announces the start of ELEVATE: A randomizEd ControlLed Study of PnEumRx™ Endobronchial Coil System (Coils) Versus Standard of Care Medical MAnagement in the Treatment of Subjects with Severe Emphysema.

The goal of ELEVATE is to confirm findings of previous randomized controlled trials with the PneumRx Endobronchial Coil System in treating patients with severe emphysema.
The RENEW study presented in May 2016, showed that Coils can safely and effectively treat severe emphysema, demonstrating a significant increase in the patient’s quality of life with improved pulmonary function and exercise ability. ELEVATE is a prospective, multicentre, randomised, controlled study to confirm these findings and further identify disease characteristics using Quantitative Computed Tomography (QCT) scans that determine which patients will respond to Coil treatment. The ELEVATE study will recruit 210 patients with severe emphysema from up to 30 experienced centres in 7 European countries.

David Hahn, MD, General Manager, PneumRx BTG, said: “The ELEVATE study advances knowledge learned from the RENEW study and uses the very latest in diagnostic technology to help identify the patients most likely to benefit from Coils. The first patient has been treated by Dr Dirk-Jan Slebos and his team at the University Medical Center Groningen in the Netherlands and we are excited to begin enrolment in the study that will further demonstrate the effectiveness of Coils in this patient population who have limited options in the treatment of their disease.”

Professor Felix Herth, Head of the Department of Internal Medicine, Pulmonology and Critical Care Medicine, at Thoraxklinik at Heidelberg University Hospital, explains: “ELEVATE continues to build on the body of clinical evidence for Bronchoscopy Lung Volume Reduction (BLVR) with Coils. It will answer open questions and is designed to confirm patient selection criteria for emphysema dominant patients. As the Principal Investigator of ELEVATE, I am very positive about this study, it will help to advance the therapy for the treatment of severe emphysema to the next level.”

Patients with severe emphysema might be eligible for the study. If you are interested in learning more about this study, please see the study description on clinicaltrials.gov NCS 03360396.

About PneumRx Endobronchial Coils

The PneumRx Endobronchial Coils are minimally invasive medical implants designed for the treatment of severe emphysema with hyperinflation.

The shape-memory nitinol Coils are indicated for use in patients with homogeneous and/or heterogeneous severe emphysema to improve quality of life, lung function, and exercise capacity.

The PneumRx Endobronchial Coil System is used in conjunction with a 2.8mm working channel therapeutic bronchoscope and fluoroscopic imaging to introduce multiple Coils into the lungs using a minimally invasive approach that requires no incision. When implanted in sub-segmental airways of the lung, each nitinol Coil is designed to: gather and compress damaged lung tissue, re-tension the airway network, reduce airway collapse and air trapping, and redirect air to healthier portions of the lung.

About Published Trials

Three randomised controlled trials document the clinical benefits of the PneumRx Endobronchial Coil System with an acceptable safety profile.

Published clinical data is available concerning the treatment of severe emphysema with PneumRx Endobronchial Coils. Three randomised controlled trials (RCTs) with up to 12 months follow-up and a total of more than 450 patients document a positive effect and acceptable safety profile.1-3 In these three RCTs (RESET1, REVOLENS3 and RENEW2) quality of life, lung function and exercise capacity were improved to a statistically significant degree by BLVR with Coils. In all three trials, the primary endpoint was met and improvement was noted in all other recorded parameters.

The patients’ quality of life score improved by more than twice the Minimal Clinically Important Difference (MCID) in all three trials4. In the opinion of experts, positive changes in the St. George's Respiratory Questionnaire (SGRQ) score reflect the decrease in breathlessness in daily life. The FEV1 values increased after BLVR with Coils in comparison to control patients, while lung RV decreased.

In addition to the RCTs, PneumRx, a BTG International group company, has conducted several open label studies and supported post-hoc analyses of the published data.

For further information contact:

BTG

Andy Burrows, VP Corporate & Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530 605

Stuart Hunt, Investor Relations Manager
+44 (0)20 7575 1582; Mobile: +44 (0)7815 778 536

Chris Sampson, Corporate Communications Director
+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178

FTI Consulting

Ben Atwell/Simon Conway
+44 (0)20 3727 1000

About BTG

BTG is a global healthcare company focused on Interventional Medicine. Our innovative medical technology helps physicians treat their patients through minimally invasive procedures. We have a growing portfolio of products that advance the treatment of cancer, vascular conditions and severe emphysema. BTG’s Pharmaceuticals business provides products that help patients overexposed to certain medications or toxins. To learn more about BTG, please visit: btgplc.com.

References

1Shah PL et al. Lancet Respir Med 2013;1:233-240.
2Sciurba FC et al. JAMA 2016;315:2178-2189.
3Deslee G et al. JAMA 2016;315:175-184.
4Jones PW et al. Eur Respir J 2002;19:398-404.