Achaogen - 2009 Fierce 15

Based: South San Francisco
Founded: 2004
Website: www.achaogen.com
CEO: Kevin Judice (photo)

The Scoop: Achaogen has set its sights on developing a new generation of antibacterials. Its lead program has just finished a Phase I safety trial with positive results, government grants have poured in and a new venture round will keep the company well financed.

What makes it Fierce:  Using some new chemistry, Achaogen has revved up an old generation of antibiotics called aminoglycosides into a next-gen approach that's dubbed neoglycosides.

"It's a very old class of antibiotics," says Achaogen CEO and CSO Kevin Judice, PhD, who helped found the company five years ago. "No one has worked on it in about 25 years."

Achaogen has developed a new approach to dosing this antibiotic. The standard approach had been to provide a patient with low dosages provided multiple times over the course of the day. But that's all wrong, says Judice. The best approach is to provide a high dose and then back off to get maximum efficacy. Combining the new antibiotic with a new dosing regimen offers a new approach that improves efficacy and reduces side effects, an ideal profile for any developer looking for an approval.

Says Judice: "We're a small company looking for an ecosystem we can have a big impact on quickly."

Achaogen just got the safety data it was looking for in Phase I and plans to go into a Phase II with 225 to 240 patients early next year. That trial should wrap in early 2011.

In the antibiotic field, it's at least theoretically possible to get an approval without conducting a Phase III trial, though there are no guarantees on that approach. Still, Judice believes that Achaogen can keep the discovery phase relatively short.

A group of top venture capital groups have chipped in $40 million to get the company up and running, but antibacterials are a key focus for public institutions and Achaogen has managed to build much of the company with their support. In biotechnology, non-dilutive cash rules, and Achaogen has commanded some $100 million of it from the likes of the Wellcome Trust, the Department of Defense and the National Institutes of Health.

The developer has three other programs fully funded by government agencies for anthrax and bubonic plague. Judice says that $50 million of the government agencies' $100 million commitment is still to come, a rich source of capital to fuel research at the company.

Even so, Judice expects to raise "a little more equity money that will prime the pump." A new round of $25 million to $30 million should do the trick. That would give the company plenty of funds to get its lead antibiotic through Phase II and a second program past Phase I. And then Achaogen can take a look at partnership possibilities.

What to look for: A mid-stage trial is looming, but Judice is already looking forward to an approval that could come in 2012 or 2013. In the meantime, Achaogen is raising more money to keep its pipeline well greased. 

Venture backers: 5AM Ventures, Arch Venture Partners, Domain Venture Partners, Venrock Associates and Versant Ventures.