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news.Topigen Pharmaceuticals has reported that the first patients have been dosed in a multi-center Phase II trial, designed to evaluate the safety, tolerability and proof-of-concept of its inhaled respiratory treatment in patients suffering from chronic obstructive pulmonary disease.
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The drug, TPI 1020, is a novel, anti-inflammatory respiratory drug licensed from NicOx for respiratory indications. The trial is expected to enroll approximately 50 evaluable patients.
The primary endpoint of this six-week study is to assess the general safety and tolerability of TPI 1020 versus budesonide as well as efficacy of TPI 1020 versus budesonide on sputum neutrophils counts. Neutrophils are inflammatory cells that are important in the pathology of chronic obstructive pulmonary disease (COPD).
Paul Wotton, president and CEO of Topigen, said: “Based on the very good safety profile and effect on inflammation seen in our recently completed Phase II study of TPI 1020 in asthmatic smokers, we plan to accelerate clinical development of the drug in COPD, and later in certain other respiratory disorders. COPD will be the primary target indication for which we plan to seek eventual marketing approval.”