PT20 is a novel iron-based phosphate binder that we are developing for the treatment of hyperphosphatemia. The manufacturing process of PT20 makes it a more efficient phosphate binder compared to iron oxide, a naturally occurring form of iron. The integration of adipic acid to form PT20 increases the phosphate binding capacity by a factor of three, compared to the unmodified iron oxide. The manufacturing process also results in particles of a very small size, which maximises the surface available for phosphate binding. The manufacturing process to integrate adipic acid is based on patented technology. Adipic acid is a naturally occurring small organic molecule. It is used in the food and packaging industry and has a good safety profile. In the body, the adipic acid in PT20 is displaced by phosphate that binds to the iron and is then absorbed through the gut, metabolised and excreted. In a Phase 2b pivotal clinical trial completed in May 2015, PT20 met all primary and secondary endpoints, demonstrating a dose dependent effect on lowering serum phosphate and generally good tolerability across the dose range. We believe that PT20 has the potential to reduce absorption of phosphate and thereby reduce blood phosphate levels in dialysis-dependent CKD patients, without many of the limitations of current therapies, such as low specificity, high pill loading, GI side effects, calcium loading, or significant toxicity concerns. A Phase III study design has been discussed with the FDA during the End of Phase II meeting.
PT20 is exclusively licensed from the Medical Research Council in the United Kingdom.
PT30 and PT40
We have two other product candidates in our pipeline, PT30 and PT40. PT30 is a novel IV iron formulation, that is designed to be a hypoallergenic, potentially overcoming one of the most significant drawbacks of current IV iron therapies. PT40 is designed to be the first generic version of IV iron sucrose, which would significantly lower cost of IV iron therapy. We plan to develop both PT30 and PT40 for the treatment of IDA. We may develop these candidates alone, or seek strategic partners to advance them through clinical development and commercialize these product candidates, if approved.