The first patient has been treated in a new randomized trial of dNerva, a targeted lung denervation therapy for patients with COPD.
According to a press release from Nuvaira, developer of the treatment, the current study, AIRFLOW-4, follows on the heels of a previous study, “Randomized Sham-Controlled Trial of Targeted Lung Denervation in Patients With Chronic Obstructive Pulmonary Disease (AIRFLOW-3).” That study was published in the American Journal of Respiratory and Critical Care Medicine.
In AIRFLOW-3, 388 patients were randomized at 32 sites. There was no difference found between the tested treatment and the sham procedure in terms of the probability of the participants having a moderate or severe COPD exacerbation. However, a post hoc analysis suggested that the failure to reach the primary endpoint was a result of an insufficient number of patients exhibiting an airway-predominant phenotype (lung hyperinflation without significant emphysema).
It was that post hoc analysis that led to the development of AIRFLOW-4. Researchers believe that “small airway disease” — characterized clinically as air trapping with minimal alveolar destruction — defined the best responders to the treatment. Further post hoc analysis of AIRFLOW-3 at one year showed meaningful improvement in lung function, exacerbation rates and quality of life in dNerva treated patients. This has raised the possibility of lung denervation as the first targeted therapy for this COPD phenotype.
“These data make sense,” said AIRFLOW-4 principal investigator Gerard Criner, PhD, chair and professor of thoracic medicine and surgery at Lewis Katz School of Medicine at Temple University in Philadelphia. “Lung hyperinflation drives symptom burden, but we have no targeted therapies for our large population with relatively low levels of emphysema. Plus, a one-time intervention reduces the burden of adherence for patients, a key advantage of this therapy.”
