TOPIGEN Pharmaceuticals, Montreal, released the results of a Phase 2 14-day study of inhalable TPI ASM8 in patients with asthma. TPI ASM8 did not demonstrate statistical significance in the primary efficacy endpoint— late asthmatic response— in patients with mild asthma following a controlled allergen challenge.
Trends were observed on other endpoints, however, that are consistent with statistically significant results observed in an earlier Phase 2 study of TPI ASM8. TOPIGEN plans to continue Phase 2 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.
TOPIGEN’S TPI ASM8 inhibits multiple targets associated with inflammation in asthma, potentially enabling a broader, but more specific, pharmacological activity with limited systemic availability and a favorable safety profile.
“We believe that TPI ASM8 has a very compelling clinical profile for the treatment of moderate to severe asthma,” says Mark Parry-Billings, PhD, chief executive officer of TOPIGEN. “We plan to expand the TPI ASM8 program with the initiation of additional dose-finding studies in the first half of 2009 and we are optimistic that we will be able to define the potential role TPI ASM8 can play in providing much needed treatment options for patients with moderate to severe asthma who do not respond adequately to the current standard of care.”