Prosonix has initiated a Phase 2 clinical study with PSX1002 that will assess its effect on lung function and the safety of a range of doses in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
The first two groups of eight patients, from up to 40 patients being enrolled, have been dosed at the Medicines Evaluation Unit in Manchester, UK, where the study is being conducted under the supervision of Professor Dave Singh. Further details of the study are below.
PSX1002 is a novel formulation of glycopyrronium bromide (GB), a long-acting muscarinic antagonist (LAMA), that is being developed as a potential ‘best-in-class’ orally inhaled monotherapy for COPD.
PSX1002 was designed using Prosonix’ proprietary particle engineering technology platform, which has enabled the Company to create, and initiate clinical studies with a simple suspension formulation of GB for delivery via a pressurized metered dose inhaler (pMDI) that does not require or contain any other extraneous carriers or functional excipients.
Dr Geoff Down, Prosonix Chief Medical Officer, added: “Glycopyrronium bromide appears to be particularly useful in reversing airway constriction in COPD patients, increasing airflow, relieving symptoms and improving quality of life. We look forward to the results in 2014.”
David Hipkiss, CEO of Prosonix commented: “This trial with PSX1002 is a very exciting step for Prosonix as it marks the first ever clinical study of a drug formulation that we have wholly created and developed in-house using our unique particle engineering technology and Respiratory Medicine by Design approach. This important milestone, along with the planned EU filing of our lead product PSX1001 in the first half of 2014, highlights the rapid progress that Prosonix is making, and the significant value we are generating for all our stakeholders who have backed our respiratory focused strategy in mono and combination products.”