BioMarck Pharmaceuticals Obtains FDA Agreement On Its Phase 2 Clinical Trial Plans
BioMarck Pharmaceuticals, a biopharmaceutical research and development company focused on new therapies for the treatment of respiratory diseases, announced recently that it has obtained agreement from the U.S. Food and Drug Administration (FDA) for its proposed plans for a Phase 2 trial of the novel respiratory drug, BIO-11006 Inhalation Solution.
Phase 1 studies of BIO-11006, an inhaled drug designed to combat the oversecretion of mucus and inflammation in diseases such as chronic obstructive pulmonary disease (COPD), asthma, and cystic fibrosis, were conducted on healthy volunteers and have demonstrated that the treatment is safe and well tolerated.
In a recently held end-of-Phase-1 meeting with FDA officials, BioMarck presented results from the BIO-11006 nonclinical toxicology program and Phase 1 clinical studies. After review, the FDA concluded that the nonclinical and clinical results presented by BioMarck support the conduct of a Phase 2 clinical efficacy and safety study in its proposed design.
BioMarck's Phase 2 clinical trial of BIO-11006 Inhalation Solution will be a multicenter, placebo-controlled, double-blind trial involving approximately 160 COPD patients. The primary objective of the study is to demonstrate that BIO-11006 treatment improves lung function in COPD patients.
BIO-11006 works by a novel dual mechanism in which it simultaneously inhibits both the over-secretion of mucus in the lungs and pulmonary inflammation. BioMarck's research and development is supported by private financing together with SBIR funding from the National Institutes of Health.
"BIO-11006 is being developed to treat two of the primary causes of many pulmonary diseases," said Indu Parikh, BioMarck's President and Chief Scientific Officer. "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 2 clinical plan is an exciting milestone in the development of a breakthrough therapy for COPD and other respiratory diseases."
About BioMarck Pharmaceuticals
BioMarck Pharmaceuticals, Ltd. is a privately owned biopharmaceutical company dedicated to the discovery and development of new drugs for the treatment of pulmonary diseases and disorders associated with the over-secretion of mucus and pulmonary inflammation in patients with chronic obstructive pulmonary disease (COPD), asthma and cystic fibrosis.
For more information, please visit: www.biomarck.com
SOURCE: BioMarck Pharmaceuticals