LONDON, UK I February 26, 2015 I Phosphate Therapeutics, today announces that recruitment of subjects into PEACH, the first pivotal trial of PT20 in subjects with hyperphosphataemia related to dialysis dependent chronic kidney disease (DD-CKD), has completed as the pre-specified number of randomisations has been achieved.

PT20, invented by leading UK-based scientists from the Medical Research Council and exclusively licensed by Phosphate Therapeutics, is a novel phosphate binder that is based on proprietary ‘Interstitial Mineral Hydroxide’ (IMH) 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’.  Data from early in vitro and in vivo studies on PT20 suggests it exhibits significant higher specificity and efficacy than market leading phosphate binders.

The PEACH study (A Pharmacodynamic Evaluation of Adipate modified iron in subjects with Chronic kidney disease and Hyperphosphataemia) is a Phase 2b, multi-centre, placebo-controlled, randomised study of PT20 in subjects who are dialysis dependent with hyperphosphataemia.  A range of doses of PT20 are being tested for effect on phosphate levels in the blood.  This study is being conducted in more than 20 expert nephrology centres in the USA, with Dr Geoff Block as the Principal Investigator.  Dr Block is a widely published and world-recognised clinical expert in the field of 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, expected in the second quarter of 2015, will help define the doses and regimen that will be taken forward into the second pivotal 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 in patients dependent on dialysis.

Commenting on this announcement, Carl Sterritt, the CEO said:  “I am pleased recruitment into this trial has completed.   We are fortunate to be working with a group of very experienced and effective renal physicians and research coordinators.  It is clear that people with kidney disease and raised phosphate levels are in need of a more effective and convenient therapy than is currently available.  Earlier studies of PT20 have displayed characteristics which we anticipate will lead to data from this study demonstrating the potential advantages of PT20 over current and in-development phosphate binders.” 

Dr Geoffrey A. Block, MD, CCRI from Denver Nephrology and Principal Investigator added: Im pleased that this first major clinical study of PT20 in patients on dialysis has completed enrolment,demonstrating the continuing need for more effective therapies for the treatment of hyperphosphataemia and also the interest held in PT20 by the expert prescriber community.  As nephrologists we are always looking to improve the care of our patients and control of phosphate is still an area for improvement.  This and future studies of PT20 will show us what contribution this novel product can make to patient benefit.

About PT20 

Invented in the UK and exclusively licensed from the Medical Research Council, PT20 is a novel iron-based phosphate binder being developed for the treatment of hyperphosphataemia related to dialysis-dependent or 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 its’ phosphate binding properties.

About hyperphosphataemia 

As kidney function declines in CKD, the ability of the body to remove and control phosphate decreases.  This results in 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.

SOURCE: Phosphagenics