AstraZeneca buoyed by late-stage trial success
pharmafile | March 18, 2015 | News story | Sales and Marketing | AstraZeneca, copd. asthma, formoterol fumarate, glycopyrronium, ptoo3, respiratory
AstraZeneca’s investigational respiratory drug has posted positive results in a Phase III trial in people with COPD, having found it improves breathing in people with the lung disease.
PT003 is a combination of glycopyrronium, and formoterol fumarate which is delivered in an inhaler developed by Pearl Therapeutics. AstraZeneca tested it in two 24-week trials to assess the benefits of PT003 on lung function.
These showed PT003 demonstrated statistically significant improvements in breathing ability versus two other investigational drugs, PT001 and PT005, and also enhanced breathing ability compared to placebo.
In a statement the British firm says it plans to file global regulatory applications for PT003 this year. Data from these studies – called PINNACLE 1 and 2, and a 28-week study called PINNACLE 3 – will be presented at a scientific meeting later in 2015, the company says.
Briggs Morrison, executive vice president of global medicines development and chief medical officer at AstraZeneca, notes: “These positive top-line results demonstrate the potential of PT003 as a novel treatment for patients suffering with the debilitating and chronic symptoms of COPD.
“The ability to deliver a unique formulation in a single device is important for helping some 30% of patients around the world who use an aerosol inhaler. Today’s results are also encouraging for the development of our investigative triple-drug combination [with] inhaled corticosteroids.”
Rival firms also have similar combination drugs that are more advanced than AstraZeneca’s PT003, but AZ’s drug is administered with novel technology that uses a pressurised meter-dose inhaler instead of a dry-powder inhaler. This may offer an advantage over competitor treatments as it could suit patients who struggle to take their medicines correctly.
The positive results will be a welcome lift for AstraZeneca, who posted mixed results in a cardiovascular outcomes trial presented earlier this week at the American College of Cardiology conference.
The British firm is committing significant investment into restoring its respiratory pipeline, having completed a deal to acquire Dublin-based firm Actavis’ branded respiratory portfolio for $700 million this month.
Lilian Anekwe
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