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.”