Singapore, Mar 11, 2010: Australian company Pharmaxis has successfully completed a phase IIa dose profiling study with its new anti-inflammatory agent ASM8 in patients with allergic asthma.

According to the company, the study met the pre-defined primary efficacy and safety endpoints and ASM8 was found to be safe at all doses tested and particularly effective at an inhaled dose of 8 mg once per day. Compared to saline control, at this dose, bronchoconstriction following allergen challenge was reduced by 32 percent during the early phase of this response and by 49 percent during the late phase of this response.

 

In addition, inflammation as measured by sputum eosinophil count, 7 hours and 24 hours following allergen challenge was reduced by 49 percent and by 57 percent respectively.

Dr Alan Robertson, Pharmaxis' Chief Executive Officer, said, “We are very encouraged by these new clinical data demonstrating the potential value of this approach for treating asthma. The moderate to severe sector of the asthma market, which is the target of ASM8, represents a significant commercial opportunity, and is under-served by current therapies.”

ASM8 was the leading clinical-stage asset in the portfolio of drug candidates acquired by Pharmaxis in its recent takeover of the Canadian company, Topigen Pharmaceuticals.

The trial was designed to determine the efficacy and safety of ASM8 at a range of doses administered sequentially via inhalation to 12 patients with asthma followed by a controlled allergen challenge. ASM8 is a combination product of two RNA-silencing oligonucleotides targeted at a number of receptors for mediators of inflammation in asthma.

Paul O'Byrne, Professor of Medicine and Chair, Department of Medicine at McMaster University, Ontario said, "Severe allergic asthma is difficult to treat and the results from this trial indicate that the approach of knocking down multiple inflammatory mediators may provide an important clinical option.”

The prevalence of asthma is estimated at 60 million in the US, Europe and Japan of which approximately, three million are classified as having severe, persistent asthma.