San Diego Business Journal

Fast-moving Lumena Pharmaceuticals Inc. has secured $45 million in Series B financing. The company will use the funding to develop drugs for two diseases of the liver — one rare and lacking in treatment options, the other a disorder that’s expanding in prevalence and market potential.

The 3-year-old company is advancing at a rapid clip, having received a hefty $23 million in Series A financing just last May. It has already completed several mid-stage clinical trials, thanks largely to the fact that it didn’t do the initial research and clinical trials. The company bought the data and rights to the drug from Pfizer Inc., where the research had been sidelined and was gathering dust for nearly a decade.

Lumena, which was founded in 2011 by North Carolina investment firm Pappas Ventures, has raised $78 million in private financings to date. New Enterprise Associates led the most recent round, along with Adage Capital Management and RA Capital Management. They join existing investors Pappas Ventures, RiverVest Venture Partners and Alta Partners.

The company’s lead drug candidate, LUM001, focuses on cholestatic liver disease, a rare condition that causes increases in the level of bile acid production, leading to extreme itching and pain. The drug has been studied in more than 1,400 patients in 12 clinical studies and has received orphan drug designation in the U.S. and Europe — a label granted to pharmaceuticals treating rare diseases that can help fast-track their regulatory approval. The company expects to submit a new drug application with the Food and Drug Administration in 2016.

Lumena is also focusing on a second drug, LUM002, to treat nonalcoholic steatohepatitis — a condition that causes inflammation of the liver. The growing rate of diabetes and obesity is triggering an expansion of the market for this condition. A recent report from research and consulting firm GlobalData forecasts that the global market for nonalcoholic steatohepatitis will grow from $233 million in 2012 to $863 million in 2017.

Lumena plans to begin a phase 2 clinical trial of LUM002 in the second half of this year. The company expects the funding will be enough to complete phase 2 trials, and then will likely search for a partner for the costlier late-stage clinical trials.

LUMENA PHARMACEUTICALS INC.

CEO: Mike Grey

Revenue: $45 million just invested in Series B; $78 million invested in total

Investors: Pappas Ventures, New Enterprise Associates, Adage Capital Management, RA Capital, RiverVest Venture Partners, Alta Partners

Headquarters: Del Mar Heights

Year founded: 2011

Company description: Developing drugs for liver disease

Key factors for success: Skipped the initial research and development portion by buying an already-studied drug candidate