Preliminary results from the trial indicate that inhaled TPI-ASM8 was safe and well tolerated and demonstrated protection in early and late stage allergic responses in patients with asthma.
The 17-patient, placebo-controlled, phase II trial was designed to assess overall safety and tolerability and to demonstrate proof-of-principle that inhaled TPI-ASM8 would show biological activity in the respiratory tract of patients with mild-to-moderate asthma. The study evaluated repeated administration of once daily doses of inhaled TPI-ASM8, given for four days at delivered doses similar to currently marketed steroids.
“This was our very first attempt to examine the activity of inhaled TPI-ASM8 in patients and these results confirmed earlier findings seen in our preclinical studies. Assuming that these data are confirmed in subsequent and larger clinical studies, we are confident that we can develop a meaningful therapeutic alternative to inhaled corticosteroids for patients with asthma,” said Dr Paolo Renzi, Topigen’s chief scientific officer.