One year after inception, San Diego-based Ocera Therapeutics Inc. completed a $14.5 million Series A financing that will help move its first product into clinical trials.
The company was founded in January 2005 with seed money from Princeton, N.J.-based Domain Associates, which co-led the first round, along with Thomas, McNerney & Partners, of Minneapolis. The funding should take Ocera through at least 18 months of operations.
Ocera also announced the in-licensing of its first and only product, AST-120, from Tokyo-based Kureha Corp. The company filed an investigational new drug application with the FDA to start late-stage clinical trials in the first half of this year.
"The $14.5 million in proceeds will go toward the completion of the first clinical trial in Crohn's disease," said Laurent Fischer, president and CEO and a co-founder of Ocera, "as well as the initiation of other clinical trials for other therapeutic indications."
The license from Kureha gives Ocera rights to develop AST-120 for gastrointestinal and liver diseases in North America and Europe, including inflammatory bowel disease (IBD). IBD affects about 1 million people in the U.S. and 4 million people worldwide. Crohn's disease represents one of the two major kinds of IBD, and affects about 500,000 patients. It is expected to have a market size of more than $1.7 billion by 2013.
"There are very few safe, oral therapeutics for the treatment of mild to moderate Crohn's disease in development," Fischer said.
AST-120 consists of orally delivered, nanoporous microspheres that absorb toxins in the gastrointestinal tract. The drug, invented and developed by Kureha, is marketed in Japan and Korea as a treatment for chronic renal failure. It has been tested in more than 200,000 patients there, and has shown promising clinical efficacy in mild to moderate Crohn's disease.
About half of all Crohn's disease patients develop fistulas, which can be "extremely debilitating from a quality-of-life standpoint," Fischer said.
Initially, Ocera will target the mild to moderate form of the disease, particularly patients who suffer from fistulas, but it could conduct trials later on for the severe form. Currently, Malvern, Pa.-based Centocor Inc.'s Remicade is indicated for the severe form, but the therapy has "significant long-term safety issues," Fischer said, including lymphoma and an increase in serious infection.
He said AST-120 might serve as a "safe and better-tolerated option or alternative."
Down the development pathway, Ocera intends to partner the compound in Europe. "Ideally, inside the U.S., we'd like to maintain marketing or co-marketing rights for specialty markets such as GI," Fischer said.
Once AST-120 gets further along in clinical development, Ocera may decide to in-license other development candidates for gastrointestinal and liver diseases. But the current focus is on developing AST-120 for a variety of indications.
In the meantime, Ocera will continue to operate somewhat as a virtual company.
"We have seven employees in San Diego," Fischer said. "We expect that we'll expand that to some degree, but our plan is to maintain a lean organization."
In addition to Fischer, Ocera was co-founded by Eckard Weber, a partner at Domain Associates.