The trial, which is expected to begin in 2014, deals with PT20, a novel iron-based phosphate binder being developed for the treatment of hyperphosphataemia related to chronic kidney disease (CKD).
“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, in a statement.
Neither Clinipace nor Phosphate were available to comment due to weather conditions.
Hyperphosphataemia is a life-threatening complication of CKD, the incidence of which is increasing as the onset of obesity and diabetes rises. The treatment of this condition is a significant unmet medical need, according to the companies.
“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. “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 [digital contract research organization] model, to ensure the trial is optimized for budget and visibility while it is being conducted.”
This is the first “of many client wins” for Clinipace, according to Cassandra Zink of Crossroads PR.
The announcement of the win for Clinipace comes after the company said it would push farther into adaptive clinical trials.