BioMarck Receives FDA Approval for Phase II Trial of Lung Drug

Research Triangle Park, N.C. — The good news keeps coming for startup BioMarck Pharmaceuticals.

The drug development firm said Monday that it has received clearance from the U.S. Food and Drug Administration to launch a Phase II clinical trial for its compound that targets chronic obstructive respiratory disease, or COPD.

The news comes just four months after BioMarck secured $4 million in new venture funding and two months after securing U.S. patent coverage for key parts of its technology.

BioMarck is developing a compound called BIO-11006, an inhalation solution, that the company has said treats the cause, not just the symptoms, of COPD.

The Phase II trial will be launched in the second quarter of this year. The trial will be designed to determine efficacy and safety of the proposed drug.

The treatment for respiratory diseases is based on technology that it has licensed from North Carolina State. The treatment is designed to combat mucus. According to BioMarck, there are no drugs that treat pulmonary disease by targeting the excessive mucus secretion. The company has also received financial support from the National Institutes of Health.

BioMarck submitted an investigational new drug to the Food and Drug Administration in December of 2005.

Kenneth Adler, a professor of cell biology at NCSU, made the discoveries that led to the development of BioMarck’s technology.

In Phase I tests, BIO-11006 was tested on healthy volunteers. The Phase II trial will involve some 160 COPD patients.

“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.”