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news.BioMarck Pharmaceuticals has obtained agreement from the FDA for its proposed plans for a multicenter, placebo-controlled, double-blind Phase II trial of the novel respiratory drug, BIO-11006 inhalation solution.
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The trial will involve approximately 160 chronic obstructive pulmonary disease (COPD) patients. The primary objective of the study is to demonstrate that BIO-11006 treatment improves lung function in COPD patients.
Indu Parikh, BioMarck’s president and chief scientific officer, said: “We are developing a first-in-class therapeutic intended to block mucus hypersecretion and pulmonary inflammation based on the discovery of a new cellular target associated with respiratory diseases. The FDA’s agreement with our proposed phase II clinical plan is an exciting milestone in the development of a breakthrough therapy for COPD and other respiratory diseases.”