Intarcia Therapeutics

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Fierce 15 Winner

Based: Emeryville, CA
Founded: 1999
Website: www.intarcia.com

The Scoop: "A fresh approach to treating hepatitis C has delivered supporting data in a series of clinical trials and could help spawn new programs related to sustained delivery of therapeutics."

What makes it Fierce: The standard of care for hepatitis C is well established: A combination of interferon and ribavirin injected weekly over the course of up to 48 weeks. But the problems with this standard are also well documented. Sustained viral responses are often not achieved and side effects associated with weekly injections can discourage the most committed patients. This population also includes a host of patients who can't tolerate injections for a variety of reasons.

Intarcia's researchers are pursuing a new approach: using a subcutaneous device to deliver a sustained course of a uniquely formulated omega interferon, what Intarcia CEO Alice Leung calls "our secret sauce."

Its potential benefits: No need for regular injections, a reduction in side effects, better compliance.

Intarcia believes that its omega interferon, a natural product derived from hamster ovary cells, delivers the kind of drug stability they need for sustained delivery. And they've backed that up recently with new Phase II data that shows sustained efficacy even among patients with genotype-1 HCV--the most difficult to treat version of hepatitis C. Combined with ribavarin, its omega interferon delivered an early viral response rate of 84 percent.

That kind of data has helped bring in a new $50 million venture round that will further advance this approach. Some of that money will be used for a Phase Ib dose-escalating trial in chronic HCV patients who have relapsed following treatment. CEO Leung says that a Phase II trial would likely be designed to demonstrate non-inferiority with the standard for care in a treatment-naïve population. Intarcia is also testing the DUROS device with doses of GLP-1 or a GLP-1 analog for Type 2 diabetes, a major disease category.

There's enough money in the bank now to get the company to the threshold of Phase III in 2009, when it can ponder going public, striking partnership deals or looking at buyout offers. "We would like to develop the company into one where we could participate in the commercialization of our products," says Leung. “We don't expect to be an international company; we had only 35 people as of June 1.”

What to look for: More data to back up Intarcia's quest for approval as a first-line therapy against hepatitis C and new work on the diabetes program. Leung says that other biotechs have also been in touch to see about a collaboration using the DUROS device, which might make sense if it doesn't prove too distracting from its lead program.