The Food and Drug Administration (FDA) has accepted BDSI's first Investigational New Drug application (IND) for its Bioral cochleate technology. BDSI is planning to test its drug in treatment of leishmaniasis, a parasitic disease, and esophageal candidiasis, an opportunistic infection in immunocompromised patients, and if successful expects to carve out a large share of the market.
The antifungal agent, amphotericin B, is the most powerful drug on the market to treat leishmaniasis but its use has been restricted because of toxicity, cost and the need to administer it intravenously, according to BDSI.
The encochleated formulation contains substances, such as soy bean phospholipids and calcium designed to encapsulate, protect and deliver drug molecules. Specifically, the technology helps fragile molecules in a matrix free of water and oxygen, protecting them during processing and extending shelf life. In addition, the natural ingredients of the formulation help keep the manufacturing cost down, according to BDSI.
The formulation is designed to protect the drug from destruction in the gastrointestinal (GI) tract. Preclinical studies have shown that the formulation carries the drug across the GI tract's mucous membrane and into the circulatory system, where it is delivered at the site of infection.
BDSI claims that there is low toxicity because the drug is concentrated at the site of infection, where circulating blood levels are low.
"CAMB [cochleated version of amphotericin B] consistently showed significant efficacy against systemic fungal infections and substantial safety levels throughout the preclinical development period using animal models," said Raphael Mannino, BDSI's chief scientific officer and executive vice president
"In addition, we believe we have developed a highly cost competitive manufacturing protocol which we expect will be advantageous as we move through the next stage of clinical testing and potential partnering discussions."
"Cochleate delivery technology is capable of formulating highly insoluble, difficult-to-work with, molecules."
The company has an ongoing program with a European pharmaceutical company and is in discussions with pharmaceutical companies over drug delivery applications.