A large-scale clinical trial failed to produce anticipated results for one of GlaxoSmithKline's (GSK) respiratory disease drugs as it did not prolong the life of the tested patients and brought down company sales.
But even as it was not seen to prolong life, the drug was seen to have other positive results.
GSK and its marketer Theravance announced Sept. 8 the initial results of the Study to Understand Mortality and MorbidITy in COPD (SUMMIT) for Relvar®/Breo® Ellipta®. The inhaled medicine Breo did not prolong life in patients who had chronic respiratory disease.
The study, conducted by Britain's biggest drug company, tested the drug on 16,485 chronic obstructive pulmonary disease (COPD) patients with moderate airflow limitation. The clinical study did not record the drug extending the life of the participants, but it did show a reduced risk of dying by 12.2 percent. Researchers, however, also note that this reduced risk, compared to the effects of a placebo, did not really show significant statistical results.
The participants' use of Breo also showed a lowered rate in the decline of lung function and in heart problems. Again, because the drug did not meet its goal of prolonging patient life, the reduced rate of declining lungs and arising heart ailments also did not reveal statistical significance.
"While we didn't achieve statistical significance on the primary endpoint, we believe the full data set will be beneficial and informative to the respiratory and cardiovascular scientific community," said the SVP and Head of the Global Respiratory Franchise at GSK, Eric Dube, highlighting the importance of SUMMIT being the first to analyze survival rates an under-researched population of co-morbid patients.
Professor Jørgen Vestbo of the Respiratory Medicine at the Centre for Respiratory Medicine and Allergy, University Hospital South Manchester NHS Foundation Trust and the University of Manchester, and also the lead investigator of the study, added that this large-scale clinical trial is the first prospective study to look at the interaction between COPD and cardiovascular disease (CVD). He noted that the study provides a huge sum of data from which clinicians can better understand the COPD and CVD, and therefore improve patient management.
In 2013, Breo was approved for COPD, also known as smoker's cough. Sales have been slow to take off at the time for the drug intended to treat the leading cause of death across the globe.
While investors hoped the large-scale clinical trial would boost GSK's sales by billions of dollars, the test results made shares fall 1.5 percent Wednesday.
"GSK remains committed to tackling the major challenges that physicians and patients face in the treatment of respiratory disease," Dube said.
