MORRISVILLE, N.C.--(BUSINESS WIRE)--Clinipace Worldwide, a global digital clinical research organization (dCRO), announced today that Phosphate Therapeutics, co-owned and resourced by Shield Therapeutics (Shield), an independent specialty pharmaceutical company, has selected the company to manage its first pivotal trial in its late stage Nephrology program expected to commence in 2014.
Clinipace will manage a pivotal trial of PT20, a novel iron-based phosphate binder being developed for the treatment of hyperphosphataemia related to chronic kidney disease (CKD).
Hyperphosphataemia is a life-threatening complication of CKD, the incidence of which is increasing globally as obesity and diabetes levels rapidly rise. The treatment of this condition is a significant unmet medical need, providing a strategic opportunity for Phosphate and Clinipace to partner in research.
"Given the gravity of the disease under study, and significant therapeutic promise shown by PT20 in early research, it was crucial for us to work with a provider that could help us complete this pivotal study quickly and effectively in order to reduce the development risk associated with the PT20 programme. We look forward to working with Clinipace on this important study," said Julian Howell, Group Medical Director, Phosphate Therapeutics Ltd.
"With the rising incidence and prevalence of kidney disease, poor outcomes and high costs associated with treatment are putting undue burdens on the global healthcare system," said Jeff Williams, CEO, Clinipace Worldwide. "With much of the expense of bringing promising drugs like PT20 to market related to the cost of clinical trials, we offer not only an experienced, therapeutically-focused team but a technology-enabled services approach, our dCRO model, to ensure the trial is optimized for budget and visibility while it is being conducted."
About Shield Therapeutics
Shield Therapeutics (www.shieldtx.com), founded in 2008, is an independent specialty pharmaceutical company focused on the development and commercialisation of late-stage, mineral-derived pharmaceuticals which address areas of high unmet medical need. Shield has successfully completed a pivotal Phase 3 programme of its lead asset, ST10, for the treatment of iron deficiency anaemia associated with inflammatory bowel disease and is soon to commence a Phase 3 study of ST10 for the treatment of iron deficiency anaemia in patients with chronic kidney disease.
Shield Therapeutics consists of Shield Holdings AG and Phosphate Therapeutics. Shield Holdings' main asset is ST10 and Phosphate Therapeutics' main asset is PT20, a novel Phase 2 ready phosphate binder for the treatment of hyperphosphataemia. As well as sharing substantially similar shareholders, Shield Holdings provides management and other critical development services to Phosphate Therapeutics.
About Clinipace Worldwide
As a global full-service digital contract research organization (dCRO), we have pioneered an innovative technology-amplified CRO service model to serve the unique needs of venture-backed, mid-tier, and strategic pharmaceutical, biotechnology, and medical device firms. Powered by TEMPO™, our proprietary eClinical platform, our team of experts brings extensive therapeutic knowledge and insight into assisting life science firms in developing and executing regulatory strategies, clinical development, and post-approval research to ensure a successful drug and medical device development program. We have managed over 1,200 global clinical research, strategic product development, regulatory, and GxP/CMC/QA projects in therapeutic areas such as cardiovascular & metabolic diseases, central nervous system, dermatology, gastroenterology, immunology, infectious diseases, nephrology, oncology, respiratory, rheumatology, and vaccines (and other cell and tissue based therapies). Clinipace Worldwide is headquartered in Research Triangle Park, North Carolina with offices in Irvine (CA), Boulder (CO), Overland Park (KS), Zurich (CH), Munich (DE), London (UK), Tel-Aviv (IL), Sao Paulo (BR), Buenos Aires (AR), Trivandrum Kerala (IN) and New Delhi (IN). For more information, visit our website at www.clinipace.com.