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news.Topigen Pharmaceuticals has completed patient enrollment in a Phase II safety and efficacy study in asthma with one of its lead product candidates, TPI ASM8.
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The current clinical study builds on prior efficacy and safety data in a three-day study of TPI ASM8 in an allergen challenge model. TPI ASM8 is a novel, inhaled, anti-inflammatory drug in development for the management of moderate or severe asthma.
This study is a Phase II, multi-center, double-blind, randomized, placebo controlled crossover study in subjects with asthma. It will evaluate TPI ASM8 given once daily by inhalation in a breath-actuated inhaler over a 14-day period.
Mark Parry-Billings, chief development officer of Topigen, said: “The completion of patient recruitment in this Phase II trial is on schedule, and represents a significant clinical achievement for Topigen. We look forward to completing the study and reporting on data at the end of this year.”