Verona Pharma plc. a U.K.-based clinical stage pharmaceutical company, recently announced positive results from a phase 2 clinical trial testing their compound RPL554. According to the company, the therapy provides extra dilation of the passageways into the lungs in patients with chronic obstructive pulmonary disease (COPD) used in combination with standard medicines (bronchodilators).
RPL554 was developed as a treatment for people with COPD who experience acute periods of worsening symptoms or exacerbation. Using RPL554 on top of salbutamol and ipratropium bromide, which are bronchodilators normally used by COPD patients, resulted in 60% extra dilation of the airways.
Professor Dave Singh, the principal investigator of the trial, said in a press release: “Achieving more than an additional 60% improvement in lung function on administration of RPL554 in moderate to severe COPD patients, already pre-treated with standard of care bronchodilators, is clinically highly significant, especially as the addition of RPL554 appears to be well tolerated.”
The clinical trial involved 30 participants with moderate to severe COPD. During the trial, participants received via an inhaler a single dose of either salbutamol or placebo, followed by a single dose of either ipratropium bromide or placebo, and finally a single dose of either RPL554 or placebo. Neither participants nor clinicians knew who was receiving what. Lung function was then measured and compared to measurements taken before the medicines were administered.
Results showed that there was a statistically significant increase in lung function when patients were given any drug on its own compared to placebo. Researchers also found that when RPL554 was given on top of either salbutamol or ipratropium bromide, the dilation of the airways was increased up to 60% more.
The study confirmed that RPL554 was well tolerated both on its own and when used in combination with salbutamol or ipratropium bromide.
In people with COPD, the airways in the lungs are inflamed and become narrower. This causes shortness of breath and poor airflow to the lungs. According to the World Health Organization (WHO), there are 65 million people worldwide who have moderate to severe COPD, and it is estimated that by 2020, COPD will be the third leading cause of death in the world. Acute periods of worsening symptoms result in 1.5 million accident and emergency department visits, 726,000 hospitalizations, and 120,000 deaths per year in the U.S. alone, according to the press release from the company.
RPL554 is a bronchodilator and an anti-inflammatory. It is currently being developed as a nebulizer for the treatment of acute exacerbations in COPD. A phase 2b clinical trial to further test the compound is expected to start in early 2017.