Lumena Pharmaceuticals is a private biopharmaceutical company dedicated to providing better treatment options for adults and children who suffer from rare and debilitating liver diseases and serious metabolic disorders. The company is focused on developing oral therapeutics to improve liver function, relieve disease symptoms and dramatically benefit patient health.
Once-Daily Oral Drug
Both of Lumena’s product candidates (LUM001 and LUM002) are inhibitors of the apical sodium-dependent bile acid transporter (ASBT), which is primarily responsible for recycling bile acids from the intestine to the liver. In the right place at the right time, bile acids are essential for good nutrition and health. But in certain types of rare liver disease, the buildup of bile acids leads to devastating symptoms such as pruritus – an itch so severe it causes patients to scratch through the skin causing bleeding, significantly reducing the quality of life. Blocking bile acid recycling in these patients has proven to slow disease progression, improve liver function and enhance quality of life, and Lumena does so with an easy to administer, once-daily drug.
Lumena is currently evaluating LUM001 in multiple Phase 2 clinical trials in rare cholestatic liver diseases including:
- Children with Alagille syndrome (ALGS), a genetic disorder characterized by extreme itching;
- Children with progressive familial intrahepatic cholestasis (PFIC), a genetic disorder that typically leads to progressive liver damage and failure;
- Adults with primary biliary cirrhosis (PBC), primarily in women ages 40-60, thought to be caused by an autoimmune process that can progress to irreversible cirrhosis and liver failure;
- Adults with primary sclerosing cholangitis (PSC), primarily men, which leads to progressive liver damage and eventually liver failure.
LUM001 has received Orphan Drug Designation from both the U.S. Food & Drug Administration and the European Medicines Agency, which allows Lumena to accelerate efforts to reach a population in desperate need of treatment.
With its newest round of financing, the company will advance to a Phase 2 clinical trial of LUM002 for the treatment of nonalcoholic steatohepatitis (NASH), a common, often “silent” liver disease characterized by fat deposits in the liver, leading to inflammation and significant fibrosis.
Mike Grey, as venture partner at Pappas Ventures, founded Lumena in 2011 with seed capital from Pappas and RiverVest. RiverVest Managing Directors John McKearn, Ph.D., and Niall O’Donnell, Ph.D., worked closely with Grey to develop the company and build a clinical proposal. The team continues to work at a rapid pace toward FDA approval.
In June 2012, Alta Partners led a $23 million Series A financing joined by Pappas and RiverVest. In March 2014, New Enterprise Associates (NEA) led a $45 million Series B financing with current investors Pappas Ventures, RiverVest Venture Partners and Alta Partners joined by new participants Adage Capital Management and RA Capital Management.
Lumena swings for a $75M IPO to bear down on liver diseases. Read more.
As Lumena continues to develop LUM001 in its ongoing global clinical programs and plans to initiate a Phase 2 clinical trial of LUM002 in 2014, the company raised $45 million in Series B financing. Read more.
LUM001 received positive opinion for Orphan Drug Designation in EU. Read more.
The first patient was dosed in the Clarity Phase 2 study of LUM001 in patients with primary biliary cirrhosis (PBC) Read more.
LUM001 received Orphan Drug Designation from USDA which allows Lumena to pursue an accelerated pathway for drug development to treat four rare liver diseases. Read more.
Company at a Glance
San Diego, CA
Mike Grey, President and CEO
Series A: $23M May 2013
Series B: $45M March 2014