SAN DIEGO and SHENZHEN, China, July 28, 2016 /PRNewswire/ — Profil Institute for Clinical Research, Inc., a science-driven clinical research organization (CRO) focused exclusively on metabolic diseases, announced today a strategic master services agreement with Shenzhen HighTide Biopharmaceutical Ltd., a subsidiary of Shenzhen Hepalink Pharmaceutical Co., Ltd.
Under the terms of the agreement, Profil Institute will provide clinical research and development services, from IND readiness through the completion of early phase development, including regulatory and scientific support services, for HighTide’s portfolio of drug candidates that address the therapeutic areas of diabetes and NAFLD/NASH.
HighTide is a US-China joint venture founded in 2011 by Dr. Liping Liu and Hepalink Pharmaceutical to progress a promising portfolio of novel therapeutic candidates from discovery to clinical development for the treatment of diabetes and NAFLD/NASH.
Profil Institute is a leading early phase CRO focused exclusively on metabolic diseases. Its experience encompasses a wide range of investigational and marketed drugs for diabetes, obesity and NAFLD/NASH, with more than 280 clinical research projects completed.
“The collaboration between HighTide and Profil Institute is based on a shared commitment to find better treatments for diabetes and related metabolic disorders through scientifically based, therapeutically focused translational research,” said Dr. Marcus Hompesch, Profil Institute Chairman and CEO. “This strategic partnership leverages the combined capabilities of Profil Institute’s metabolic expertise and services in clinical development and HighTide’s robust metabolic drug portfolio and capacity to bring new and impactful therapies to the market globally.”
“Profil Institute has already provided expert strategic and operational support through phase I activities for HighTide’s islet regeneration peptide HTD4010. We’re pleased to expand our access to their expertise and services through a preferred CRO strategic partnership,” said Dr. Liping Liu, HighTide CEO and CSO. “Profil Institute’s deep scientific expertise in metabolic disease, combined with their longstanding reputation and experience in early phase development, were key factors in our selecting them as a partner to oversee, design and execute the clinical development initiatives for our pipeline of diabetes and NAFLD/NASH drug candidates.”
About Islet Regeneration Peptide HTD4010
Insulin-dependent diabetes is characterized by loss or dysfunction of beta cells, contained within pancreatic islet cells. Although type 1 and 2 diabetes differ in their pathogenesis, islet cell regeneration is a promising therapy for both diseases. HighTide’s islet regeneration peptide HTD4010 is expected to enter phase II clinical trials in early 2017.
Non-alcoholic fatty liver disease (NAFLD) is a condition characterized by excess fat deposition in the liver and is a common comorbidity of diabetes and obesity. A subset of patients with NAFLD progress to develop non-alcoholic steatohepatitis (NASH), which can result in cirrhosis, hepatocellular carcinoma, and liver failure, often necessitating liver transplantation.1
About HighTide Biopharmaceutical Ltd.
HighTide Biopharmaceutical Ltd. is a subsidiary of Shenzhen Hepalink Pharmaceutical Co., Ltd. The company is focused on the development of novel therapeutics for the treatment of diabetes and chronic metabolic diseases with significant unmet medical needs. For more information, visit www.hightidebio.com.
About Profil Institute for Clinical Research, Inc.
Profil Institute is full-service clinical research organization (CRO) focused on diabetes, obesity and NAFLD/NASH. Profil Institute’s team of experts in clinical development work with clients throughout the U.S., Europe and Asia 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 provider2. For more information, visit www.profilinstitute.com.
1 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.
2 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 Profil Institute for Clinical Research, Inc.