AstraZeneca recently presented encouraging data from its phase III PINNACLE program focused on evaluating PT003 as a potential treatment for chronic obstructive pulmonary disease (COPD). The program is comprised of two 24-week pivotal studies, entitled PINNACLE 1 and PINNACLE 2, and the top-line results revealed its effectiveness in improving patients’ lung function.
The PINNACLE 1 and PINNACLE 2 studies had as their primary objective the evaluation of lung function benefits, measured by the trough forced expiratory volume in one second (FEV1), as announced by the company in a press release. The research revealed that there were significant improvements in the trough FEV1 of patients who were treated with PT003 compared to ones who received PT001, PT005 and placebo, while PT001 and PT005 also caused statistically significant improvements in trough FEV1 compared to placebo.
PT003 is a combined therapy that includes long-acting muscarinic antagonist (LAMA), glycopyrronium, and the long-acting beta-2 agonist (LABA), formoterol fumarate. The treatment is comprised of twice a day doses and is the first combined therapy delivered in a pressurized metered dose inhaler (pMDI) with a novel porous particle co-suspension technology developed by Pearl Therapeutics, a company that was acquired by AstraZeneca two years ago.
“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,” said the executive vice president of Global Medicines Development and chief medical officer at AstraZeneca, Briggs Morrison. “The ability to deliver a unique LAMA/LABA formulation in a single pressurized metered dose device is important for helping some 30% of patients around the world who use an aerosol inhaler.”
The most reported adverse events in the studies were nasopharyngitis, upper respiratory tract infection, and dyspnea, which occurred in all treatment groups, including placebo. In addition, the incidence of adverse events was also usually identical through all treatment groups. In addition to the phase III program, AstraZeneca also conducted an extension study that lasted 28 weeks, called PINNACLE 3, in order to obtain safety information.
“Today’s results are also encouraging for the development of our investigative triple-drug combination of LAMA/LABA and inhaled corticosteroids,” added Morrison, as he announced that the company expects to submit global regulatory applications for PT003 using the results of the PINNACLE 1, 2, and 3 Phase III studies, which are going to be presented at a scientific meeting this year.
The company also recently announced that it will be sponsoring a program from the COPD Foundation, called COPD360 program, which is an innovative initiative to boost research and promote new approaches for COPD. The COPD360 program was designed to comprise one of the largest networks of COPD patients and will enroll 125,000 patients through integrated research registry databases composed of physicians’ registries and the COPD Patient-Powered Research Network.