Lumena Raises $23 Million to Advance Drug for Rare Liver Diseases

San Diego-based Lumena Pharmaceuticals says today it has raised $23 million in a Series A round that is intended to carry the company through mid-stage trials of its lead drug candidate for treating a rare group of metabolic disorders that cause bile acid to build up in the liver.

Advancing the drug, LUM001, as a potential treatment for cholestatic liver diseases has been something of a case study in perseverance, according to Mike Grey of Pappas Ventures. Grey has been serving as the company’s CEO since Lumena was founded in 2011. He previously headed San Diego’s Auspex Pharmaceuticals, SGX Pharmaceuticals, and Trega Biosciences.

Lumena in-licensed LUM001 from Pfizer, which had conducted extensive clinical trails of the drug for its potential as a cholesterol-lowering compound, Grey told me by phone yesterday. More than 1,400 people had participated in 12 clinical trials before Pfizer decided to halt development.

But Grey said the drug had a champion in John McKearn, a managing director at RiverVest Venture Partners. McKearn remembered the compound from his years as head of discovery research at Pharmacia. Pfizer acquired the Swedish drug maker in 2002. The RiverVest director co-founded Lumena with Grey to revive development of the drug, and the two VC firms provided seed funding.

Alta Partners joined with RiverVest and Pappas to provide funding for today’s Series A round.

LUM001 is being developed as a possible therapy for cholestatic liver diseases, which cause bile acids to build up in the liver and in blood serum, leading to progressive liver damage and physical symptoms that include an intense and insatiable itch. Current treatment typically requires a surgical procedure that diverts bile into an ostomy bag. The surgery can lower bile acid levels and improve liver function, but at some cost to patients’ quality of life.

Bile acids are chemicals that are made by the liver from cholesterol. They help to absorb fats and fat-soluble vitamins. Most of the bile acids secreted by the liver are reabsorbed in the last portion of the small intestine, but choleastic liver diseases prevent bile acids from being reabsorbed.

Lumena says clinical studies have shown that LUM001 can reduce serum bile acid levels and may be effective in managing symptoms in many patients with cholestatic liver diseases. The company plans to begin a mid-stage trial of the drug in adults with Primary Biliary Cirrhosis, which causes inflammation and damage of the bile ducts in the liver. The company also plans to initiate mid-stage studies of LUM001 in children with rare congenital types of cholestatic liver disease known as Alagille Syndrome and Progressive Familial Intrahepatic Cholestasis.

In a statement from the company, RiverVest’s McKearn says, “LUM001 could dramatically impact patient health for a population in desperate need of more effective treatment options, and we are glad to be a part of this potentially game-changing company.”

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.