London, UK, 5 March 2012. Phosphate Therapeutics, an independent specialty pharmaceutical company focused on the development of mineral-derived hospital pharmaceuticals, today announces that it has signed an exclusive agreement with the Medical Research Council (MRC) to acquire the global rights to PT20, a novel Phase 2 ready phosphate binder for the treatment of hyperphosphataemia.  The PT20 programme was initially supported by funding from the MRC’s Development Gap Fund and this deal was negotiated by MRC Technology on behalf of MRC.  At the same time funding of up to €10.5m has been secured from Inventages Venture Capital (Inventages) to complete the Phase 2 development of PT20.

Patients with late-stage renal disease suffer from systemic phosphate accumulation, hyperphosphataemia, which enhances the risk of vascular calcification, leading to increased morbidity and mortality.  Low phosphate diets and regular dialysis sessions are unable to prevent gradual phosphate accumulation, therefore, oral phosphate binders are required to reduce blood phosphate levels.  Current treatments are often limited by at least one of the following problems: limited therapeutic dosing range, low specificity, high pill loading, gastrointestinal side effects, calcium loading or significant toxicity concerns.

PT20 is a novel phosphate binder with robust global IP protection that is based on adipate-doped iron oxide technology, allowing it to act as a ‘phosphate sponge’.  Discovered and initially developed through clinical Phase 1 by MRC scientists based at the Human Nutrition Research Unit in Cambridge, UK; PT20 exhibits high specificity and efficacy in phosphate binding both in vitro and in vivo.  In early studies PT20 appears to display characteristics that may position it as superior to current or known pipeline phosphate binders as it has the potential to overcome the key disadvantages in this class of therapeutics.  Phosphate Therapeutics expects to initiate a confirmatory Phase I pharmacokinetic study in H2-2012 and initiate a Phase II dose-escalating, comparator study in 2013 for the treatment of hyperphosphataemia in patients with pre-dialysis and dialysis-dependent chronic kidney disease (CKD).

“We are pleased to have acquired PT20 from the Medical Research Council and secured funding from Inventages to further develop this high quality asset in addition to the Phase 3 development of ST10 for the treatment of iron deficiency anaemia in patients with CKD.  It is evident that CKD patients also suffering with hyperphosphataemia are in need of a more effective therapy for this serious complication and we look forward to building upon the work already undertaken by the MRC on this programme to deliver a more effective therapy option.” said Carl Sterritt, CEO of Phosphate Therapeutics.

Professor Jonathan Powell of the MRC Human Nutrition Research unit added: “Our research carries a heavy emphasis of timely translation of new findings to the benefit of patients or the population, so it is gratifying to see that our synthetic biominerals platform technology, which was first patented in 2007, has already produced a phase 2-ready therapeutic in the form of PT20.  Current phosphate binders for patients with end stage renal disease have clear shortfalls and PT20 has been designed with these in mind to address the patients’ unmet needs.  We look forward to working with Phosphate Therapeutics and their partners to continue the progress of PT20 towards clinical usage”.

Walter Stockinger, Principal of Inventages commented: “We are excited to work on this project with our partners from Phosphate Therapeutics. The treatment of hyperphosphataemia is clearly an area with large unmet medical need and we are convinced that PT20 will improve the quality of life and the outcome for a group of patients who suffer from chronic kidney disease. PT20 has shown superior clinical efficacy in early studies and has a lower than normal development risk, making this project the ideal candidate for our funds. Phosphate Therapeutics is working with an experienced team that we have come to know very well and we trust in their ability to bring the product to the market in the shortest possible time.”