MipSalus is granted an Orphan Drug Designation for Phelimin from EMA

November 2016: On October 6, based on scientific evidence produced by MipSalus, the European Medicines Agency (EMA) announced that MipSalus’ Phelimin has potential as treatment of Phenylketonuria (PKU). Following the announcement, the European Commission granted Phelimin an Orphan Drug Designation on November 18, 2016. The EU orphan designation number is, EU/3/16/1784, and the designation is published in the Community Register of Orphan Medicinal Products and can be accessed in all the official languages of the European Union on EMA’s website.

Meet us at BioEurope Spring 2016

April 2016: MipSalus participates in BioEurope Spring 2016 in Stockholm. BioEurope is the premier springtime partnering event for biotech and pharmaceutical companies, academic innovators, investors and others. CEO Nicolas Krogh and CSO Klaus Gregorius will represent MipSalus.

Studies show promising results for breakthrough treatment of PKU

March 2016: Together with Aarhus University, Mipsalus has concluded studies which evidence our technology in an animal model. The purpose of the studies was to document that MipSalus’ MIP-based product binds phenylalanine in the gastrointestinal tract. In combination with Phelimin, mice with PKU were fed a high-protein diet, and the studies showed that Phelimin reduces the level of phenylalanine by approx. 70% in mice fed with high-protein. The studies have been conducted with phenylalanine levels that are clinically relevant if proportionally scaled up to humans.

Grant for feasibility study of a home sensor

February 2016: MipSalus receives a DKK 0.5 million grant from the Innovation Fund Denmark. The money will be used to conduct a feasibility study for a home sensor which will allow PKU patients to monitor the concentration of phenylalanine in their blood.

Under current practice, PKU patients are offered a few phenylalanine tests per month. However, this practice is both expensive and time-consuming: PKU clinics draw blood from patients and forward samples to laboratories for analysis. Following the analysis, the laboratories return the test results to the PKU clinics who then inform their patients.

As a testament of the need for a better solution, the National PKU Alliance (a PKU advocacy group based in the US) issued a worldwide challenge to the scientific and technical community to develop a phenylalanine home sensor in 2013. This challenge with has not yet been met. MipSalus’ feasibility study is intended to establish all technical aspects necessary for the development of a proto type of the home sensor.