NEW PBC RESEARCH
Lumena is an early stage biotech company focused on better treatment options for adults and children living with rare cholestatic liver diseases. Lumena currently has two compounds aimed at not only carrying a reduced risk of systemic toxicities by selectively targeting a transporter in the intestine but is also designed to be minimally absorbed in the body. Phase II studies in children with Alagille syndrome and adults with primary biliary cirrhosis (PBC) have been initiated. In addition, studies in children with progressive familial intrahepatic cholestasis (PFIC) and adults with primary sclerosing cholangitis (PSC) are being planned.
“CLARITY”
PBC Study Newsletter Article
New Hope for Patients with Primary Biliary Cirrhosis
We have exciting news to share for patients with Primary Biliary Cirrhosis (PBC) regarding an investigational study that may help alleviate the symptoms of itching related to PBC. Lumena Pharmaceuticals initiated a new study and is currently enrolling patients with PBC and moderate to severe pruritus (itching). The study is a Phase II international, multi-center trial of LUM001.
LUM001, an investigational oral therapeutic, has been studied in 12 clinical trials in more than 1,400 people. Previous studies have indicated that LUM001 can reduce serum bile acid levels, which may be offer therapeutic benefit to patients with PBC and manage the pruritus that affects patient quality of life. In previous trials, LUM001 was generally tolerated, with the most common side effect being gastrointestinal disturbance.
The trial, known as CLARITY, is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of LUM001. The study will enroll approximately 60 patients. The primary endpoint of the study is change from baseline in pruritus compared to placebo. Secondary endpoints include changes in liver enzymes and other biochemical markers of cholestatic liver disease compared to placebo.
As patients know too well, cholestatic liver diseases are characterized by elevated bile acids and severe itching, which can be debilitating for some patients. To date, treatments with anti-pruritics typically provide only modest relief and procedures that remove bile from the circulation can lower serum bile acids and relieve symptoms in some patients, but tend to be invasive in nature. By reducing serum bile acids with an oral, once-daily tablet, the investigational drug LUM001 may offer a novel approach to the treatment of PBC and alleviation of pruritus.
Lumena Pharmaceuticals
NEEDED PATIENTS TO PARTICIPATE in Lumena Pharmaceuticals….Please participate if you can. This is for ALL of US!
Below is a list of the centers where patients can participate in this study.
Sites in the United States
California
Scripps Clinic, La Jolla , California , United States , 92037
Contact: Marjory Simpson 858-652-5420 simpson.marjory@scrippshealth.org
University of California at Davis, Sacramento , California , United States , 95817
Contact: Sandeep Dhaliwal 916-734-8985 sandeep.dhaliwal@ucdmc.ucdavis.edu
Florida
University of Miami, Miami , Florida , United States , 33136
Contact: Marlene McGregory 305-243-2148 MmcGregory@med.miami.edu
Illinois
University of Chicago Medical Center, Chicago , Illinois , United States , 60637
Contact: Monique Williams 773-702-4477 mwillia3@bsd.uchicago.edu
Indiana
Indiana University, Indianapolis , Indiana , United States , 46202
Contact: Rachel Limbach 317-278-9355 rlimbach@iu.edu
Kentucky
University of Louisville, Louisville , Kentucky , United States , 40202
Contact: Lisa Hatter 502-852-3383 lisa.hatter@louisville.edu
Michigan
Henry Ford Health System, Detroit , Michigan , United States , 48202
Contact: Kimberly Baker 313-916-1979 kbaker@hfhs.org
Minnesota
Minnesota Gastroenterology, Plymouth , Minnesota , United States , 55446
Contact: Leon Heller 612-870-5597 Leon.Heller@mngastro.com
Missouri
St. Louis University, St. Louis , Missouri , United States , 63104
Contact: Dorothy Heller 314-977-9389 dorothyheller@slu.edu
New York
Weill Cornell Medical College, New York, New York , United States , 10021
Contact: James Maier 646-962-5394 jam2078@med.cornell.edu
Texas
University of Texas Southwestern Medical Center, Dallas , Texas , United States , 75390
Contact: Rebecca Chason 214-415-0983 Rebecca.Chason@utsouthwestern.edu
Advanced Liver Therapies at St. Lukes Episcopal Hospital, Houston , Texas , United States , 77030
Contact: Beth Dietrich 832-355-8966 bdietrich@stlukeshealth.org
Utah
University of Utah Health Science Center, Salt Lake City , Utah , United States , 84132
Contact: Tiffany Tomkinson 801-585-9155 tiffany.tomkinson@hsc.utah.edu
Virginia
Liver Institute of Virginia, Newport News , Virginia , United States , 23602
Contact: Suzette Tipps 757-947-3190 suzette_tipps@bshsi.org
Hunter Holmes McGuire VA Medical Center, Richmond , Virginia , United States , 23224
Contact: Jennifer Salvatori 804-675-6924 jennifer.salvatori@va.gov
Washington
University of Washington Harborview Medical Center, Seattle , Washington , United States , 98104
Contact: Carly Gintz 206-744-3479 cgintz@medicine.washington.edu
Sites in the United Kingdom
University of Birmingham, Birmingham , England , United Kingdom , B15 2TT
Contact: Darren Barton 44 (0) 121 414 8255 d.barton@bham.ac.uk
Newcastle University, Newcastle , England , United Kingdom , NE1 4LP
Contact: Jennifer Bainbridge 0191 282 0070 j.m.bainbridge@newcastle.ac.uk
Oxford University Hospitals, Oxford , England , United Kingdom
Contact: Madeleine Thyssen 01865 231618 Endoscopy.researchsisters@orh.nhs.uk
Imperial College London St Mary's Hospital, London , United Kingdom , W2 1NY
Secondary link: lumenapharma.com/lumena-pha...
__._,_.___
