Jeffrey Stein is president and CEO of Cidara Therapeutics, one of the few companies working to develop drugs to fight fungal infections.

Jeffrey Stein is president and CEO of Cidara Therapeutics, one of the few companies working to develop drugs to fight fungal infections. Photo by Melissa Jacobs.

Over the past decade, many drugmakers stopped trying to fight superbugs, citing high research costs, poor returns and too much red tape.

But now, after repeated warnings about mutating strains along with some new profit incentives local biotechs are returning to the front lines.

Cidara Therapeutics is one such firm. A San Diego company chockfull of industry veterans, Cidara is developing a promising drug to address a particularly dangerous fungal infection that affects hospitalized patients.

While super strains of bacteria usually receive all the media attention, fungi can be equally deadly, especially when it enters the bloodstream.

“The consequence of getting a fungal infection can be far more dire than getting a typical bacterial or viral infection,” said Jeffrey Stein, president and CEO of Cidara.

This is particularly true in patients with weakened immune systems, such as those undergoing an organ or bone marrow transplant, chemotherapy or a patient with AIDS. To make matters worse, these patients often are on more than one medication, raising the demand for anti-infectives that play nice with other drugs.

But anti-fungals are probably the most-neglected field in infectious disease, Stein said. Why? Well, because it’s hard. Fungi are complex organisms.

“Developing a safe and effective drug for pathogenic fungi is really challenging,” Stein said. “And in fact there are only three classes of drugs that combat fungal infections, two of which are very toxic.”

Historically, anti-fungals also bring in less revenue and are expensive to develop. But changing regulatory pathways are looking more navigable, and Stein said Cidara has a plan for creating value.

Fighting Infection

To start, Cidara is developing a novel molecule drug called CD101 IV, designed to treat Candida fungal infections that have reached the bloodstream. These infections include candidemia, which is associated with extremely high mortality rates.

According to a recent peer-reviewed study, 3.5 in 10 candidemia patients die within 12 weeks of diagnosis. Further, it is estimated that each case of candidemia results in an additional 23 days of hospitalization and over $68,000 in treatment costs.

Early data suggest that treating systemic Candida infections with CD101 IV should enable early discharge from the hospital, reducing hospital costs and improving compliance for outpatients, thereby reducing the rise in drug-resistant fungal pathogens.

Cidara has received fast-track approval from the U.S. Food and Drug Administration, meaning regulators recognized the potential of the drug and intend to communicate more frequently with Cidara to speed CD101 IV’s development. The company expects to have Phase 1 data by the end of this year.