Pharmaceutical Business review

Phosphate to manage Clinipace’s Phase II trial of PT20 to treat hyperphosphataemia

Under the deal, Clinipace will manage a major trial of PT20, a new iron-based phosphate binder, being developed for the treatment of hyperphosphataemia related to chronic kidney disease (CKD).

The company said that Hyperphosphataemia is a life-threatening complication of CKD, the incidence of which is increasing globally as obesity and diabetes levels rapidly rise.

Phosphate Therapeutics group medical director Julian Howell said, "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."

Clinipace Worldwide CEO Jeff Williams said 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.

"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," Williams said.

Shield Therapeutics has already completed a major Phase III programme of its lead asset, ST10, for the treatment of iron deficiency anaemia associated with inflammatory bowel disease and is planning to start a Phase III trial of ST10 to treat iron deficiency anaemia in patients with CKD.