LONDON, May 7, 2015 /PRNewswire/ --
Phosphate Therapeutics Limited ("Phosphate Therapeutics"), a development-stage specialty pharmaceuticals company, today announces positive results from the PEACH pivotal study of PT20 in subjects with hyperphosphataemia related to dialysis dependent chronic kidney disease (DD-CKD).
PT20, invented in the UK by leading Cambridge-based scientists and exclusively licensed by Phosphate Therapeutics, is a novel phosphate binder that is based on proprietary 'Interstitial Mineral Hydroxide' technology that uses adipate-doped iron oxide at the core of the product, thereby allowing PT20 to act as a very high capacity 'phosphate sponge'.
This first pivotal study of PT20 in approximately 150 subjects with hyperphosphataemia related to DD-CKD, clearly met its primary endpoint (p<0.0001) demonstrating that PT20 successfully lowered serum phosphate levels compared to placebo, whilst all secondary analyses of the primary endpoint were also statistically significant (p<0.01). All of the study's PT20 dose groups showed a phosphate reduction at day 28 compared to baseline and this reduction was dose-related. PT20 was very well tolerated with less than 5% of the patients who received study medication withdrawing because of adverse events; and no Serious Adverse Events were considered related to study medication.
The PEACH study (A Pharmacodynamic Evaluation of Adipate modified iron in subjects with Chronic kidney disease and Hyperphosphataemia) was a pivotal Phase 2b, multi-centre, placebo-controlled, randomised study of a wide range of doses of PT20 in dialysis dependent subjects with hyperphosphataemia. This study was conducted in more than 20 expert nephrology centres in the USA, with Dr Geoffrey Block as the Principal Investigator. Dr Block is a widely published and world-recognised clinical expert in kidney disease and mineral metabolism disorders and is Adjunct Professor of Medicine at University of Colorado, as well as Director of Clinical Research at Denver Nephrology.
The results from this study will help define the treatment regimen that will be taken forward into the phase 3 study of PT20 in dialysis dependent patients. The data from these two studies are then expected to form the basis for new drug applications to the FDA and other Health Authorities for the approval of PT20 in the control of hyperphosphataemia, initially in patients dependent on dialysis.
Commenting on this announcement, Carl Sterritt, CEO of Phosphate Therapeutics, said: "These results demonstrate that PT20 can safely and effectively lower serum phosphate levels in patients with hyperphosphataemia. The results suggest that PT20 has the potential to offer benefit to patients so we are looking forward to working proactively with regulatory authorities to rapidly progress PT20 through its next pivotal trial."
Dr Geoffrey Block, MD, the study's lead Investigator also commented: "The highly positive results of this first pivotal study of PT20 provide a very encouraging start to the clinical pathway of this exciting product. The management of end stage renal disease inherently carries a large treatment burden for the patient and having an iron-based phosphate binder with such an apparently positive safety and efficacy profile at this stage of development suggests the product could be of high clinical value to both doctors and patients in the future."
Invented in the UK and exclusively licensed from the Medical Research Council, PT20 is a novel iron-based phosphate binder being developed for the eventual treatment of hyperphosphataemia related to dialysis-dependent and dialysis-independent chronic kidney disease. PT20 binds phosphate from the diet, in the gut, into a non-absorbable form. PT20 is composed of ferric iron that has been modified through the addition of adipic acid (a naturally occurring small molecule) to create a 'sponge' like structure and improve the product's phosphate binding properties.
As kidney function declines in CKD, the ability of the body to remove and control phosphate decreases. This results in serum phosphate levels in the blood rising, leading to a series of changes that cause bone weakening and calcification in arteries. The vascular disease associated with CKD is a leading cause of morbidity and death in patients. International guidelines on the care of patients with CKD recommend controlling blood phosphate levels through dietary restriction and oral phosphate binders. As diet and dialysis are rarely effective alone in meeting the target phosphate levels, over ninety per cent of patients on dialysis support will use a phosphate binder.
About Phosphate Therapeutics
Phosphate Therapeutics is a development-stage specialty pharmaceuticals company developing products for indications with substantial unmet medical needs.
For more information about Phosphate Therapeutics, please contact:
Consilium Strategic Communications
Mary-Jane Elliott / Matthew Neal / Lindsey Neville / Hendrik Thys
SOURCE Shield Therapeutics