Prosonix has developed PSX1002 as a drug-only pMDI suspension formulation. A Phase 2a clinical trial in patients diagnosed with moderate-to-severe COPD was initiated in May 2013. All patient dosing sessions and follow-up procedures were completed in August 2013, and top-line results are expected in Q1 2014.
PSX1002 requires no extraneous carrier materials or excipients, is straightforward to manufacture and offers a good safety profile. 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, thereby presenting an opportunity to maximise its commercial potential in developed and emerging economies. A capsule-based DPI presentation is also being considered.
Prosonix’ engineered GB also underpins its PSX2000 MCP™ programmes for novel combination respiratory therapies, in which it is combined with known LABA and ICS molecules in proprietary MCP™ formulations.
According the World Health Organization*, approximately 65 million people worldwide had COPD in 2004 and it is predicted to become the third leading cause of death by 2020. A limited number of mono and combination therapies are approved for this indication and together these products generated sales of more than $8 billion in 2011 in the seven major markets.
LAMAs accounted for approximately $3 billion in sales from this total and Datamonitor* estimates that sales of this class of product will remain stable through 2020. In addition, a cDPI mono-dose format of GB was approved in the EU and in Japan in 2012, with analyst estimates for annual sales in these markets of up to $1 billion.
Estimates vary for the growth of the global market for COPD therapies, with Decision Resources* anticipating it to grow 4.6% per annum exceeding $13 billion in annual sales in 2019. Significant product opportunities exist for drug-only formulations in pMDI or DPI, and novel dual and triple combination therapies.
*The Global Burden of Disease: 2004 update, 2008
Datamonitor COPD November2011 HC000218
Decision Resources, Chronic Obstructive Pulmonary Disease, 2007