Topigen reports results from Phase II asthma trial

Following a controlled allergen challenge in patients with mild asthma, TPI ASM8 did not demonstrate statistical significance in the primary efficacy endpoint – late asthmatic response. However, trends were observed on other endpoints that are consistent with statistically significant results observed in an earlier Phase II study, the company said.

Approximately 18 patients enrolled in the study received TPI ASM8. A difference versus placebo in late asthmatic response was not seen and while TPI ASM8 attenuated the rise in sputum eosinophils post allergen challenge by 50%, this difference in comparison to placebo did not achieve statistical significance.

Topigen believes that a blunted and variable response to allergen challenge may have impacted the ability to discriminate a treatment effect. TPI ASM8 continued to generate a positive safety profile and was well tolerated with no reported serious adverse events.

The company plans to continue Phase II clinical development of TPI ASM8 with the initiation of a further trial in patients with asthma and additional toxicology studies to support longer-term trials and regulatory agency review.

Mark Parry-Billings, CEO of Topigen, said: We believe that TPI ASM8 has a very compelling clinical profile for the treatment of moderate to severe asthma. We plan to expand the TPI ASM8 program with the initiation of additional dose-finding studies in the first half of 2009.