SAN DIEGO, Oct. 28, 2015 /PRNewswire/ -- Profil Institute for Clinical Research, a clinical research organization (CRO) focused on diabetes, obesity and NAFLD/NASH, announced today a collaboration of experts in biomarker discovery and clinical research in the fields of metabolism, diabetes and obesity to address the medical challenges of NAFLD and NASH.
Profil Institute is partnering with KineMed, Inc., a drug discovery and development company, and Dr. Rohit Loomba, founding director of UC San Diego's NAFLD Translational Research Unit and founder and principal investigator of the San Diego Integrated NAFLD Research Consortium (SINC). Through the collaboration, the partners will pursue biomarker alternatives to liver biopsy; improve clinical trial design for NAFLD and NASH; and begin using validated biomarkers in clinical research for clients.
About non-alcoholic fatty liver disease (NAFLD)
Non-alcoholic fatty liver disease (NAFLD) is a condition indicated by excess fat deposition in the liver and is a comorbidity of metabolic syndrome, obesity and diabetes. NAFLD is rapidly becoming the most common liver disease globally with population-based estimates ranging from 20 to 30%.1, 2 Among patients with type 2 diabetes, the reported prevalence of NAFLD is 65%.3 In patients with severe obesity, the prevalence of NAFLD can exceed 90%.1, 2
Approximately 10–22% of patients with NAFLD have the progressive subtype non-alcoholic steatohepatitis (NASH), which can result in cirrhosis, hepatocellular carcinoma, and liver failure, often necessitating liver transplantation. 4
Due to a lack of specific methodologies and biomarkers for NAFLD and NASH research, clinical studies to date have struggled to distinguish the effect of a drug from other influences. NAFLD diagnosis is established by abnormal liver chemistry, imaging studies (usually starting with ultrasound) and liver biopsy being reserved for select cases at risk for NASH or advanced fibrosis. However, imaging methods, such as abdominal ultrasonography and computed tomography, generally used to track changes in fatty liver prognosis, have low sensitivity and specificity. Liver biopsy has many drawbacks, such as sampling limitations, cost, and risk of complications. The aim is to improve the sensitivity and specificity of imaging techniques and replace needle biopsy with non-invasive biomarkers.
"Profil Institute and its partners are conducting studies using highly sensitive investigation techniques, including state-of-the-art hepatic imaging and robust methods for quantifying metabolic fluxes, including insulin action on hepatic glucose production and quantification of de novo lipogenesis. No other centers are able to offer this combination of methodologies along with the requisite research expertise and ready access to a multiethnic population representative of the treatment population," commented Dr. Marcus Hompesch, Profil Institute's President and CEO.
NAFLD/NASH Research Partners
The contributions of Profil Institute and its partners in relation to NAFLD/NASH are listed below.
Profil Institute for Clinical Research, Inc.:
- Clinical research and development of new therapeutics
- Validation of non-invasive novel biomarkers
- Patient database to study biomarkers longitudinally and across different phenotypes and treatment modalities
- Disease pathogenesis investigator initiated research
- NAFLD/NASH circulating biomarker discovery using stable isotope/mass spectrometric methods
Dr. Rohit Loomba
- Dr. Loomba, one of the nation's preeminent experts on NAFLD/NASH, will advise directly on clinical study design and protocols
About Profil Institute for Clinical Research, Inc.
Profil Institute is an early engagement clinical research organization (CRO) exclusively focused on metabolic diseases, including diabetes, obesity and NAFLD/NASH. The company is recognized globally for its scientific expertise, expanded scope of research methodologies, and experience with every clinically relevant drug class in diabetes. Profil Institute provides a full scope of CRO services from consulting for strategic clinical development and regulatory planning through design and completion of complex clinical trials, including the reporting and publication of final study results.
Profil Institute has completed more than 230 clinical trials focused on metabolism, including diabetes, obesity and NAFLD/NASH. Profil Institute is leveraging that deep expertise in metabolic disease to become the leading CRO pursuing solutions for the unmet medical needs of NAFLD/NASH patients.
Profil Institute's expertise and experience encompasses small and large molecule therapies, biologics and biosimilars through all routes of administration, as well as devices. The company's clients range from large pharma and drug discovery companies to small virtual companies throughout the Americas, Europe and Asia.
Profil Institute is also widely recognized as an innovator of methodologies, including its Automated Glucose Clamp technology, and for driving new, higher standards in metabolic clinical research through collaborative science with key academic and industry partners. For more information, please visit www.profilinstitute.com.
Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The Diagnosis and Management of Non-Alcoholic Fatty Liver Disease: Practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23.
Ahmed M. Non-alcoholic fatty liver disease in 2015. World Journal of Hepatology. 2015;7:1450-9.
Doycheva I, Cui J, Nguyen P, Costa EA, Hooker J, Hofflich H, Bettencourt R, Brouha S, Sirlin CB, Loomba R. Non-invasive screening of diabetics in primary care for NAFLD and advanced fibrosis by MRI and MRE. Aliment Pharmacol Ther. 2015 Sep 15. doi: 10.1111/apt.13405.
Bazick J, Donithan M, Neuschwander-Tetri B, Kleiner D, Brunt E, Wilson L, Doo E, Lavine J, Tonascia J, Loomba R. Clinical Model for NASH and Advanced Fibrosis in Adult Patients With Diabetes and NAFLD: Guidelines for Referral in NAFLD. Diabetes Care. 2015 Apr;10.2337/dc14-1239.
SOURCE Profil Institute for Clinical Research