Nuvaira, a medical device company, announced the upcoming publication of several scientific studies detailing the findings of clinical trials that assessed the safety and effectiveness of its Targeted Lung Denervation (TLD) therapy in patients with chronic obstructive pulmonary disease (COPD).
Nuvaira’s proprietary TLD therapy works to disrupt pulmonary nerve input to a patient’s lungs — a procedure known as lung denervation — to prevent nerve signals in the brain from reaching the lungs, and vice-versa. By disrupting this brain-lung connection, TLD stimulates smooth muscle relaxation and reduces the production of mucus in the airways, making it easier for people with COPD or asthma to breathe.
“The concept is thus to move the pulmonary system from a state of heightened neural activity, which is associated with increased exacerbations and symptom burden, to a state of attenuated neural activity, to decrease exacerbations and symptoms,” the company states on a webpage.
TLD is based on the use of Nuvaira’s dNerva Lung Denervation System, in which a console delivers a radiofrequency energy signal that travels through a special catheter to destroy (ablate) nerves in the lungs. The console also contains a heating plate and a pump that cools the fluid circulating inside the catheter, to avoid damaging the airways.
The procedure is performed through a regular bronchoscopy — in which a physician inserts a flexible lighted tube into a person’s lungs through the mouth or nose to examine the bronchi — and does not require invasive surgery.
Its safety and feasibility were evaluated in three different clinical trials to date, whose findings will be described in three research studies accepted for publication in two international and peer-reviewed journals, Nuvaira said in a press release that also briefly described these upcoming studies.
One research article will cover the findings of the pilot and single-center, proof-of-concept Phase 1a IPS-II trial (NCT01716598), in which Arschang Valipour and colleagues present data showing that the lung nerves of COPD patients who underwent TLD therapy were successfully disrupted.
In another, Dirk-Jan Slebos and colleagues report one-year data from the multicenter and randomized Phase 2a AIRFLOW-1 trial (NCT02058459), showing that TLD is a safe and feasible treatment option for patients with moderate-to-severe COPD.
Both these manuscripts will appear in the journal Respiration.
In the final study, accepted for publication in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), Pallav Shah and colleagues describe the findings of the multicenter, double-blinded, randomized, and sham-controlled Phase 2b AIRFLOW-2 trial (NCT02058459).
AIRFLOW-2 is the second phase of AIRFLOW-1, and is focused on assessing symptom worsening (adverse events) in 82 COPD patients, all with moderate-to-severe disease and experiencing debilitating symptoms despite treatments to manage their disease.
Trial investigators found that patients given TLD therapy were less likely to have exacerbations requiring hospitalization than those given the sham procedure and serving as a control group. As in previous trials, no one developed hemoptysis (coughing up blood) or pneumothorax (collapsed lung) as a side effect of treatment.
“These publications contribute to a growing body of literature supporting the therapeutic potential of Targeted Lung Denervation to meet a significant unmet medical need in patients with symptomatic COPD,” the company said.
A Phase 3 clinical trial (NCT03639051), called AIRFLOW-3, to evaluate the safety and efficacy of TLD in COPD is currently recruiting eligible patients at sites in the U.S., the Netherlands, and the U.K.