Speciality pharmaceutical company Prosonix has began the PSX1002 Phase 2 study in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Designed by Prosonix based on its particle engineering technology platform, the Psx1002 is an orally inhaled novel drug-only formulation of glycopyrronium bromide.
Prosonix chief medical officer Dr Geoff Down said that glycopyrronium bromide was likely to be useful in reversing airway constriction in COPD patients, increasing airflow, relieving symptoms and improving quality of life.
The randomised, double-blind study is designed to assess the efficacy of PSX1002 on lung function, tolerability and safety of a range of doses compared to placebo, delivered through pressurised metered dose inhaler (pMDI) in COPD patients.
A total of 40 patients are expected to be enrolled in the study, while dosing of initial two groups of eight patients was carried at the Medicines Evaluation Unit in Manchester, UK.
Improved lung function as measured by forced expiratory volume in one second (FEV1) area under the curve from time zero to 24 hours post dose is the primary endpoint.
The study will also assess several physiological (lung function) and pharmacokinetic endpoints.
Prosonix CEO David Hipkiss said the trial was the first ever clinical study of a drug formulation that the company completely created and developed in-house using the 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," Hipkiss said.
The company expects to release the results in early 2014.
Image: A chest X-ray demonstrating severe COPD. Photo: courtesy of James Heilman, MD.