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."
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