July 25, 2014 10:27 AM ET

Biotechnology

Company Overview of Lumena Pharmaceuticals Inc.

Company Overview

Lumena Pharmaceuticals Inc. develops and commercializes oral therapeutics for cholestatic liver diseases and metabolic disorders. The company’s lead product candidate includes LUM001, an orally-administered, potent, and selective apical sodium-dependent bile acid transporter (ASBT) inhibitor that is in Phase II clinical trials in children for the treatment of orphan cholestatic liver diseases comprising Alagille syndrome and progressive familial intrahepatic cholestasis, as well as is in Phase II clinical trials in adults for the treatment of primary biliary cirrhosis and primary sclerosing cholangitis. It also develops LUM002, orally-administered, potent, and selective ASBT inhibitor has co...

12531 High Bluff Drive

Suite 110

San Diego, CA 92130

United States

Founded in 2011

12 Employees

Phone:

858-461-0694

Fax:

850-350-2399

Key Executives for Lumena Pharmaceuticals Inc.

Co-Founder
Age: 61
Vice President of Pharmacology
Chief Financial Officer and Principal Accounting Officer
Age: 51
Chief Operating Officer
Age: 42
Chief Medical Officer
Age: 53
Compensation as of Fiscal Year 2014.

Lumena Pharmaceuticals Inc. Key Developments

Lumena Pharmaceuticals, Inc. Auditor Raises 'Going Concern' Doubt

Lumena Pharmaceuticals, Inc. filed its S-1 on Apr 02, 2014 for the period ending Dec 31, 2013. In this report its auditor, Ernst & Young LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern.

Lumena Seeks Acquisitions

Lumena Pharmaceuticals, Inc. seeks acquisitions. Lumena has filed an IPO in the amount of $75 million. Lumena will use the proceeds for development of LUM001, to fund the development of LUM002; and the remainder to fund working capital, including general operating expenses and pre-commercialization activities. Lumena may also use a portion of the remaining net proceeds to in-license, acquire, or invest in complementary businesses, technologies, products or assets.

Lumena Pharmaceuticals Initiates the CLARITY Phase II Study of LUM001 in Patients with Primary Biliary Cirrhosis

Lumena Pharmaceuticals announced the dosing of the first patient in the CLARITY Phase II study of its drug candidate LUM001 in patients with primary biliary cirrhosis (PBC). LUM001 is being developed as a possible therapy for a number of cholestatic liver diseases including, PBC, Alagille syndrome, progressive familial intrahepatic cholestasis and primary sclerosing cholangitis, that result in impaired bile acid flow and retention of bile acids in the liver, leading to progressive liver damage and, ultimately, liver failure. In the CLARITY Phase II study, LUM001 is being evaluated for its ability to alleviate the symptom of severe itching associated with PBC. Cholestatic liver diseases are characterized by elevated bile acids and severe itching, which is generally the most debilitating symptom afflicting adults and children with these diseases. Treatment with anti-pruritics typically provides only modest relief. Procedures that remove bile from the circulation can lower serum bile acids, reducing itch and improving liver function in some patients, but tend to be invasive in nature. LUM001 is an inhibitor of the apical sodium-dependent bile acid transporter (ASBT), which recycles intestinal bile acids back into the circulation. By reducing serum bile acids with a once-daily oral tablet, LUM001 may offer a novel therapeutic approach for alleviating the severe itching and progressive liver damage associated with many cholestatic liver diseases. The CLARITY study is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of LUM001 in combination with ursodeoxycholic acid (UDCA) versus UDCA plus placebo in adults with PBC. This international, multi-center study will enroll 60 adult patients experiencing moderate to severe pruritus (itching). The primary endpoint of the study is change from baseline in pruritus compared to placebo. Secondary endpoints include changes from baseline in liver enzymes and other biochemical markers of cholestatic liver disease compared to placebo. LUM001 has received Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) Office of Orphan Product Development in four rare cholestatic liver diseases including primary biliary cirrhosis; progressive familial intrahepatic cholestasis; Alagille syndrome; and primary sclerosing cholangitis. LUM001 has been studied in 12 clinical trials in more than 1,400 subjects. In previous trials, LUM001 was shown to be generally well tolerated, the most common side effect, gastrointestinal disturbance, was usually mild and transient in nature. Clinical studies have demonstrated that LUM001 can reduce serum bile acid levels. Reductions in bile acids may be effective in alleviating symptoms and improving liver function in many patients with cholestatic liver disease. The company has also initiated a global clinical program to study LUM001 in children with Alagille syndrome and will initiate Phase II studies in patients with progressive familial intrahepatic cholestasis, and primary sclerosing cholangitis in late 2013.

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Recent Private Companies Transactions

Type
Date
Target
Merger/Acquisition
May 12, 2014
--
Private Placement
March 7, 2014
--
 

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