Profil Institute for Clinical Research, Inc., a clinical research organization (CRO) focused exclusively on metabolic diseases, and Antaros Medical, an advanced clinical imaging research and methodology company, announced today a strategic collaboration to apply a broad range of non-invasive PET/MRI imaging techniques into pre- and postmarketing studies of cardiometabolic drugs and drug candidates.
Under the terms of the agreement, the companies plan to jointly design and conduct single and multi-center clinical studies that employ advanced PET/MRI applications to interrogate the mechanistic effects of novel therapeutics for diabetes, obesity, and non-alcoholic fatty liver disease (NAFLD/NASH). Additionally, the partners plan to assess the potential of functional imaging readouts as non-invasive biomarkers to assess the prognosis and progression, as well as predict responses to experimental therapeutic interventions, in metabolic diseases such as NAFLD/NASH.
“Advanced functional imaging techniques can yield unique mechanistic insights to enhance decision making in cardiometabolic drug development across important areas of clinical research such as heart failure, microvascular dysfunction, atherosclerosis, myocardial fuel metabolism, tissue specific insulin resistance, diabetic nephropathy and hepatic steatosis, inflammation and fibrosis,” said Johannes Hulthe, M.D., PhD, Antaros Medical CEO. “By partnering with Profil Institute for Clinical Research, a leading metabolism-focused CRO with extensive expertise and experience in diabetes, obesity and NAFLD/NASH, we have created an exciting opportunity to work collaboratively at the forefront of innovation in cardiometabolic clinical research.”
“We’re very pleased to have Antaros join our network of Metabolic Research Partners, a group of select collaborators pursuing novel methodologies and setting high standards in cardiometabolic drug and device development,” said Dr. Christian Weyer, president and CDO of Profil Institute for Clinical Research. “The advanced functional imaging techniques developed by the Antaros team represent powerful methods for use in clinical trials, and valuable biomarkers indicative of disease activity and therapeutic responses, to better inform clinical and regulatory strategy and decision-making.”
About Antaros Medical
Antaros Medical is a drug development technology innovator based in the BioventureHub at AstraZeneca Gothenburg and in Uppsala, Sweden. Antaros Medical is pioneering new frontiers in innovative MRI and PET imaging techniques, leading to improved, evidence-based decision making in clinical drug development. Antaros Medical’s clients are spread across the globe and develop new treatments for patients suffering primarily from cardiovascular and metabolic diseases. For more information: www.antarosmedical.com.
About Profil Institute for Clinical Research, Inc.
Profil Institute for Clinical Research is full-service clinical research organization focused on diabetes, obesity and NAFLD/NASH. The company’s team of experts in clinical development work globally with clients to support their metabolic drug and device candidates from IND/CTA and NDA/ANDA regulatory filing to final report publication and licensing support. The company’s experience in early phase clinical research for metabolism is unparalleled, having completed more phase I/II diabetes studies in the U.S. than any other provider1. For more information: www.profilinstitute.com.
______________________________________________
1 U.S. clinical trial data in diabetes, showing that Profil Institute’s early phase facility in Chula Vista has completed more Ph I/II T1DM and T2DM studies in the U.S. than any other clinical research site, provided by Citeline’s SiteTrove, a service offered by Informa Pharma Intelligence, April 2016
(Source: PR Newswire)
