The ENHANCE-1 and ENHANCE-2 trials investigated the efficacy and safety of ensifentrine, a novel PDE3 and PDE4 inhibitor for the treatment of patients with COPD. touchRESPIRATORY were delighted to speak with Prof. Antonio Anzueto (South Texas Veterans Healthcare System, University of Texas Health, San Antonio, TX, USA) around the aims, design, inclusion criteria and finding from the studies.
The abstract ‘Effect of Ensifentrine, a Novel PDE3 and PDE4 Inhibitor, on Lung Function, Symptoms and Exacerbations in Patients With COPD: The Enhance Trials.‘ was presented at ATS 2023, 19-24 May 2023.
Questions
- What were the inclusion criteria of the ENHANCE studies? (0:17)
- Could you give us a brief overview of the efficacy and safety profile of ensifentrine? (1:02)
- What were the findings in terms of lung function, symptoms and exacerbations? (2:20)
Disclosures: Antonio Anzueto discloses consulting for Astra/Zeneca, GlaxoSmithKline, Theravance, Viatrix, and Verona Pharma; serving on advisory boards for Astra/Zeneca, GlaxoSmithKline, Theravance, Viatrix, and Verona Pharma; receiving honoraria/honorarium from Astra/Zeneca, GlaxoSmithKline, Theravance, Viatrix, and Verona Pharma and participating in speaker’s bureaus with Astra/Zeneca, GlaxoSmithKline, Theravance, and Viatrix.
Support:Â Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones.
Filmed in coverage of the ATS Annual Meeting.
Click here for more content on COPD.
Transcript
What were the inclusion criteria of the ENHANCE studies? (0:17)
So these were patients who were diagnosed with COPD, they had to be symptomatic, so they will have an mMRC more than two, and they have an FEV-1 between 30-70%. At the end of the day, the cohort is a cohort of patients with GOLD B label. So patients with a milder form of the disease, very symptomatic with comorbid conditions that 40% were only receiving short acting bronchodilators, and 60% were receiving ICS LABA or LAMA. So that the medication showed to be very effective without concomitant medication and with concomitant medications.
Could you give us a brief overview of the efficacy and safety profile of ensifentrine? (1:02)
The efficacy shows that all the endpoints were met in reference to lung function and there is so the ENHANCE 1 AND ENHANCE 2 trials, they were the three month studies. But in the ENHANCE 1, there was also a one year follow-up for 48 weeks. Primarily looking for safety, as well as efficacy. Lung function is improved, there is a significant reduction in exacerbations around 30%, and that effect is sustained over time and the one year follow-up, that effects continue after, you know, a longer time period. Now, the important issue is safety, the phosphodiesterase inhibitors, the main problem has been safety in the past, this is a dual medication, it’s nebulized. They say there was no safety signals, there was no safety issues at the end of the 48 week trial, there were eight patients who got diarrhoea versus stool in the placebo. The diarrhoea were in intermittent episodes that occurred two or three months into therapy. So, we were not able to identify any significant safety issues and all the safety signals that we had from the oral phosphodiesterase, we’re not seen here.
What were the findings in terms of lung function, symptoms and exacerbations? (2:20)
There is an improvement in lung function, this translates to a significant improvement in patients’ quality of life. St. George’s Respiratory Questionnaire, the ERS symptoms questionnaire, they all were significantly improved. There is some of the components of the St. George’s Respiratory Questionnaire that have to do with symptoms. We saw minus six, minus eight points improvement. This is really an astonishing improvement in patient symptoms. Some patients really felt much, much better taking the medication and they had less exacerbations. So overall, the studies show, yes, it’s efficacious in improving lung function, and this translates in significant reduction in both exacerbation and significant improvement in patients’ quality of life, with having no safety signal.
Subtitles and transcript are autogenerated.
