LONDON (Alliance News) - GlaxoSmithKline PLC said Monday that its Phase IIIb/IV study with Gilead Sciences Inc for a combination therapy of ambrisentan and tadalafil for the treatment of patients with pulmonary arterial hypertension met its primary endpoint.
The treatment showed superiority compared to monotherapy treatment, Glaxo said, and the length of time before patients experienced clinical failure was significantly prolonged for those receiving the combination compared to monotherapy.
Statistically significant improvements were also shown for three of the secondary endpoints, with the remaining two secondary endpoints not meeting statistically significance.
Glaxo said that it intends to seek approval for the combination by submitting data to regulators in the US, EU and rest of the world.
The study data was presented at the European Respiratory Society Congress, where Glaxo has been presenting a spate of study data.
Glaxo also released positive data from two Phase III studies of its asthma treatment mepolizumab, and presented data that show blood eosinophil levels could help predict which patients with chronic obstructive pulmonary disease will have a greater reduction in exacerbation rates when being treated with an inhaled corticosteroid regimen.
As part of its activities at the congress, Glaxo said that it was teaming with the Global Initiative for Chronic Obstructive Lung Disease and COPD Foundation to announce the formation of a new Governance board to help promote and encourage further uptake of the COPD Assessment Test, known as the CAT.
The CAT test is used to measure the impact of COPD on a persons life, measuring a number of symptoms, to help guide discussions and enhance doctor-patient communications, the company said.
The main focus of the board will be to maximise the use and value of the test for patients, healthcare professionals and researchers. It will also explore the potential of CAT as a drug development tool.
Glaxo will hold the copyright and provide administrative support to protect the integrity of CAT, it said.
Shares in Glaxo were trading 1.9% lower at 1,420.00 pence Monday afternoon.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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