Calixa Passes Key Safety Test in Clinical Trial of New Antibiotic

3/24/09Follow @xconomy

MRSA is the headline-grabbing boogeyman of the day when it comes to the type of deadly infections that people can pick up in the hospital. But there are all sorts of other nasty bugs crawling around your healthcare facility, and San Diego-based Calixa Therapeutics says it is on its way to creating a new drug to fight one of them.

Calixa, which has remained stealthy for its first couple years in business, is announcing today that it has passed a Phase I clinical trial of 64 healthy volunteers, which shows its antibiotic for pseudomonal infections appears safe. The drug appears to have a good enough profile to move into the next phase during the second quarter, with a study of about 100 patients that will provide a measure of its effectiveness.

Calixa got its start when it raised a hefty $30 million in a Series A venture financing in November 2007 from some big-name venture firms, Domain Associates, Frazier Healthcare Ventures, and Canaan Partners. The investors are betting on Calixa’s ability to develop CXA-101, a new type of cephalosporin antibiotic, which is used against pseudomonas infections. This bug infects about four people out of every 1,000 discharged from the hospital, accounting for roughly one-tenth of all hospital-acquired infections, according to the Centers for Disease Control and Prevention. Like other better-known bugs like MRSA or “C.Diff”, it is developing resistance to many common antibiotics, and can kill people.

The basic premise behind Calixa is to give doctors more weapons to knock down the invader. This type of infection made headlines back in January when Mariana Bridi da Costa, a 20-year-old model, died after picking up pseudomonas through a urinary tract infection.

“This is a nasty bug, and there’s an unmet medical need,” says James Ge, the company’s chief scientific officer.

Calixa is led by CEO Eckard Weber, a partner with Domain who has been associated with a slew of notable biotech companies. The most notable ones in the world of antibiotics were Peninsula Pharmaceuticals, which was sold to Johnson & Johnson in 2005, and Cerexa, acquired by Forest Laboratories in 2007. Before joining the new company, Ge worked at both of those companies, too.

Calixa may have raised a load of money in 2007, but it’s running lean, with just four full-time employees, three part-timers, and about 10 consultants, Ge says. “It’s a very experienced team, we know what we’re doing.”

The company will face some competition from incumbent products made by Merck and AstraZeneca, although one of the reasons Ge likes its chances is that there are a lot fewer companies trying to tackle pseudomonas than MRSA. “There aren’t too many drugs like ours in the pipeline,” Ge says.

Calixa still has plenty of work to do in developing the drug. It’s given intravenously, and the company still needs to decide the dosing regimen—will it be twice a day or three times, and for how long? Hospital antibiotics typically are given on a 5 to 14 day course of treatment, and those parameters need to be pinned down, Ge says.

Calixa has been stealthy until now because it didn’t need to tell its story to raise money, Ge says. But there always comes a point where that is necessary, and to explain to the physician community what they’re doing. Calixa expects to present details on this Phase I trial in September at the biggest annual meeting of infectious disease experts, the Interscience Conference on Antimicrobials and Chemotherapy, or ICAAC. It’s pronounced Ick-ack, for those who have never been there.

Last night, Calixa posted its first corporate website, which provides some basic information on the who, what, when, and why. But the ICAAC meeting sounds like it will a more important coming-out party. “That will be the first time we really talk to the public,” Ge says.

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