SAN DIEGO and EMERYVILLE, CA, October 28, 2015 – Profil Institute for Clinical Research, Inc., a clinical research organization (CRO) focused on diabetes, obesity and NAFLD/NASH, and KineMed, Inc., a drug discovery and development company, announced today a collaboration to validate and begin using new noninvasive circulating biomarkers within clinical research for fatty liver disease.
Both Profil Institute and KineMed have leveraged their work in diabetes, obesity and metabolic disease to address non-alcoholic fatty liver disease (NAFLD) and the associated non-alcoholic steatohepatitis (NASH). Together, the companies will collaborate on the discovery and validation of new biomarkers to improve the diagnosis, prognosis and development of therapeutics for NAFLD/NASH.
KineMed will use its stable isotope labeling, mass spectrometry, and other technologies to identify relevant circulating biomarkers. Profil Institute will use its specific metabolic methodologies to validate the biomarkers for use in NAFLD/NASH clinical research while also utilizing its large patient database to study biomarkers longitudinally and across different phenotypes and treatment modalities. Through the collaboration, the companies will pursue biomarker alternatives to liver biopsy; improve clinical trial design for NAFLD/NASH; and begin using validated biomarkers in clinical research for clients.
About non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)
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
The current gold-standard diagnostic is a complicated, painful and sometimes risky liver biopsy. Given its difficulty and the large number of people with the disease, liver biopsy is an impractical and inadequate clinical solution. As a result, the population of patients confirmed as having NAFLD/NASH is limited.
Due to a lack of specific methodologies and biomarkers for NAFLD/NASH research, clinical studies to date have struggled to distinguish the effect of a drug from other influences. Therapeutic agents that are presently considered the most promising in NAFLD are effective in less than 50% of patients and that percentage is far less in patients diagnosed with NASH.5
“The challenges hindering research into fatty liver disease, its diagnosis, and potential therapies underscore the urgent need for the development of noninvasive biomarkers. We’re very pleased to be partnering with KineMed, which is revolutionizing circulated biomarkers discovery for NAFLD/NASH. Together we will gain a better understanding of the disease and establish new highly specific clinical research methodologies to develop effective treatments,” said Dr. Marcus Hompesch, Profil Institute’s President and CEO.
“Profil Institute is the CRO with the experience and scientific expertise that, when combined with the complementary expertise and technology at KineMed, promises to make this a transformative collaboration for the advancement of NAFLD/NASH research,” said David Fineman, KineMed’s CEO.
About KineMed, Inc.
KineMed is a life sciences company that is using its dynamic proteomics platform to develop drugs more efficiently and with less risk. Dynamic proteomics, in a single sample, rapidly detects target engagement, tracks disease progression and provides data that are highly predictive of late-stage success. The previously unavailable molecular biochemistry behind our non-invasive kinetic measurements is based upon the body’s metabolic incorporation of safe, non-radioactive tags into newly synthesized molecules through disease-modifying pathways. The rates, or activity, of these disease-modifying metabolic pathways are measured by highly sensitive mass spectrometric analytic techniques. Our technology platform, developed and validated over the past decade, establishes early proof-of-concept, target validation, pharmacodynamics, evidence of toxicity, and optimal dose. We apply our dynamic proteomics platform to our biopharma-partners’ drug assets as well as in advancing our own pipeline. For more information, please visit www.kinemed.com.
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.
For further information, please contact:
+1 (858) 663-6148
- 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. 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.
- Rinella ME, Loomba R, Caldwell SH, Kowdley K, Charlton M, Tetri B, Harrison SA. Controversies in the Diagnosis and Management of NAFLD and NASH. Gastroenterol Hepatol (N Y). 2014 Apr;10(4):219-27.