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news.Topigen Pharmaceuticals has commenced a second phase II trial with its respiratory drug which it believes is the first RNA-targeting drug with demonstrated efficacy in respiratory patients.
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This phase II study is commencing as a result of initial positive phase II results indicating that the drug known as TPI ASM8 demonstrated protection in early and late stage allergic responses in patients with allergic asthma.
The study is being conducted to evaluate the effects of TPI ASM8 given for a longer duration and to confirm efficacy at different doses. This phase II study will assess and compare the safety, tolerability and efficacy of inhaled TPI ASM8 with a placebo administered once a day for fourteen days in adult patients of chronic allergic asthma.
The primary objective of the study is to compare the efficacy of the two dosages of inhaled TPI ASM8 against placebo at reducing sputum eosinophils in subjects with asthma, as well as to assess safety and tolerability.
“We also believe that TPI ASM8 has the potential to treat allergic disorders in sites other than the lung such as allergic conjunctivitis of the eye, allergic rhinitis, and allergic dermatitis and there is long-term potential for expanded indications,” commented Dr Paolo Renzi, chief scientific officer of Topigen.