Prosonix has developed PSX1002 as a drug-only pMDI suspension formulation. A Phase 2a clinical study in patients diagnosed with moderate-to-severe COPD has been completed, with positive top-line results reported in January 2014.
The randomised, double-blind, single-dose study met its primary endpoint of demonstrating that PSX1002 improved lung function in COPD patients for a range of doses of PSX1002, compared to placebo. Good tolerability and safety profiles were observed for all doses of PSX1002 investigated.
PSX1002 requires no extraneous carrier materials or excipients and is straightforward to manufacture. Because of its engineered heritage, the product does not have the need for any ‘cold chain supply,’ and hence can be delivered from through simple pMDI multi-dose devices (vs current single-dose DPI products).
Prosonix’ engineered glycopyrronium bromide also underpins its PSX2000/3000 MCP™ programmes for novel combination respiratory therapies, in which it is combined with known LABA and ICS molecules in proprietary MCP™ formulations.
Glycopyrronium bromide is the active component in Novartis’ Seebri® Breezhaler®, a DPI formulation for COPD which was approved in Japan and in the EU in 2012 and is now also approved in several other countries. According the World Health Organization, approximately 64 million people worldwide had COPD in 2004 and it is predicted to become the third leading cause of death by 2030. A limited number of mono and combination therapies are approved for this indication and analysts estimate the monotherapy segment will be worth over $3 billion in 20221. Significant product opportunities exist for drug-only formulations in pMDI, and novel dual and triple combination therapies.
1Respiratory Market 2025: Taking a deep breath and a deep dive – Jefferies 2013 Equity Research