PT 003 positive in Phase III studies for COPD- AstraZeneca

AstraZeneca announced positive top-line results from the Phase III PINNACLE programme, which included two pivotal 24-week studies (PINNACLE 1 and PINNACLE 2) to investigate the potential of PT 003 to improve lung function in patients with Chronic Obstructive Pulmonary Disease (COPD). PT 003 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). PT 003 is 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 in 2013. The development programme also included assessment of the individual components of PT003 � glycopyrronium pMDI (PT001) and formoterol fumarate (PT005) pMDI. The successful completion of the PINNACLE studies marks the first Phase III outcomes from a series of pipeline candidates under development by AstraZeneca using Pearl�s novel technology.

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 PT 001 and PT 005 also demonstrated statistically significant improvements in trough FEV1 compared to placebo. In PINNACLE 1 and PINNACLE 2, the most common adverse events across all treatment arms, including placebo, were nasopharyngitis, upper respiratory tract infection, and dyspnea. The incidence of adverse events was generally similar across all treatment groups. The Phase III programme also included a 28-week extension study, PINNACLE 3, the safety information from which is not yet available.

Comment: PT 003 follows behind Anoro Ellipta from GSK (approved EU and US), Ultibro Breezhaler from Novartis (filed US and EU approved), Boehringer Ingelheim's Spiriva Respimat Soft Mist Inhaler (olodaterol/tiotropium) (filed in US and EU) and Dualkir Genuair (aclidinium bromide + formoterol) originally with Forest Labs/Actavis and now with AstraZeneca (filed in US and EU). Pearl Therapeutics originator of PT 003 commented that its twice-daily dosing regimen will work best for patients, putting them at an advantage over other once-daily drugs that won't have the same kind of therapeutic benefit for patients when they need it most. "It fits the times they need the drug,morning and evenings.".