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AstraZeneca scores in final lung disease drug trials

The firm hopes it LAMA/LABA drug can take a big chunk from the $14bn COPD market

AZ London HQ 

After seeing one COPD drug fail a late-stage trial last year AZ will be celebrating the latest results for its new LAMA/LABA treatment PT003.

The Anglo-Swedish firm's phase III PINNACLE programme, which included two pivotal 24-week studies (PINNACLE 1 and PINNACLE 2), were set up to investigate the potential of PT003 to improve lung function in patients with chronic obstructive pulmonary disease (COPD).

PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA).

It is also the first LAMA/LABA combination to be delivered in a pressurised metered dose inhaler (pMDI) using the unique porous particle co-suspension technology developed by Pearl Therapeutics, which was acquired by AstraZeneca two years ago for $1.15bn.

In both the PINNACLE 1 and PINNACLE 2 studies, the primary objective was to assess benefits on lung function as measured by trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in trough FEV1 versus PT001, PT005 and placebo.

Both PT001 and PT005 also demonstrated statistically significant improvements in trough FEV1 compared to placebo.

The firm is not, however, the only one in this space as there are already a number of pharma companies that have progressed LAMA/LABA drugs ahead of AZ, including treatments from big players such as Boehringer, GlaxoSmithKline, Novartis and Forest/Almirall.

But the company may have an edge over the competition as PT003 is administered with a pressurised meter-dose inhaler instead of a dry-powder inhaler that its rivals offer - something which may suit elderly patients in particular.

Briggs Morrison, executive VP of global medicines development and chief medical officer at AstraZeneca, explains: “The ability to deliver a unique LAMA/LABA formulation in a single pressurised metered dose device is important for helping some 30% of patients around the world who use an aerosol inhaler. [These] results are also encouraging for the development of our investigative triple-drug combination of LAMA/LABA and inhaled corticosteroids.”

The COPD market is expected to jump from $10bn in 2013 to $14bn by 2018, and AZ will hope to gain a large proportion of this.

AZ already sells a combination beta agonist/corticosteroid product for COPD called Symbicort (fotmoterol/budesonide), although this has now started to face generic competition in some markets.

The firm is also developing benralizumab in late-stage trials for a number of respiratory diseases and has said it believes this drug could be worth $2bn a year at its peak. But this took a hit last year when data for severe COPD showed the treatment failed to stop flare ups in patients.

AstraZeneca says in a statement that it plans to file global regulatory applications for PT003 later this year with data from the PINNACLE 1, 2, and 3 phase III studies set to be presented at a scientific meeting in the summer.

18th March 2015

From: Research

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