Promising Results from Preliminary Safety Study
July 2017: A preliminary 2-week safety study was performed by oral administration of MIPs particles to four groups BALB/c mice (5 mice per group), three times a day for one and two weeks, respectively. No difference was observed between the treated and non-treated (control) groups at all parameters tested:
- Weight and general well-being, as well as food and water intake were recorded daily or every other day.
- Macroscopic examination on stomach and intestine scoring histological changes, intestine content, and autolysis (intestine).
- Tumor Necrosis Factor in blood was measured by ELISA after one and two weeks.
The said results confirm the assumption that both the polymer making up Phelimin and the particles themselves behave inert in the mouse GI tract when dosed at a level suitable to prevent accumulation from a normal diet in a PKU mouse.
Multi-dose studies with Phelimin show high efficacy and flexibility
April 2017: Multi-dose studies document Phelimin to be very effective in regulating the phenylalanine uptake from dietary proteins. PKU mice were treated for two days with three administrations of Phelimin and dietary proteins per day. Three different dosing levels of Phelimin were tested and the lowest Phelimin dose was able to stabilize the blood phenylalanine at a normal, low level. The untreated control group had a significant accumulation of blood phenylalanine over the two days. The studies document a strong Phelimin dose-response effect, meaning that the phenylalanine uptake can be regulated at the individual meal-level. Hence, the patients can regulate their blood phenylalanine very efficiently by dosing Phelimin according to each meal and therefore has the freedom e.g. to eat many small meals or fewer larger meals of normal food – whatever he or she finds appropriate.
Correction of information published on GeneFo’s homepage
April 2017: On April 14, 2017, GeneFo announced that MipSalus’ upcoming medicinal product Phelimin for treatment of PKU had been approved by EU authorities and was awaiting approval in US. This is not correct and GeneFo has removed the information. However, Phelimin shows very promising effect in preclinical studies (see the latest release of animal data) and we expect to initiate clinical trials within 24 months.
We highly appreciate the interest from PKU patients for our Phelimin and see it as an additional confirmation of the de facto unmet medical need existing for PKU patients and it encourages us to work even harder to transform the very promising preclinical data into clinical trials.
Orphan Drug Designation for Phelimin
October 2016: Based on scientific evidence produced by MipSalus the European Medicines Agency (EMA) has on October 6, 2016 announced that MipSalus’ Phelimin has potential as treatment of Phenylketonuria (PKU). The European Commission has therefore on November 18, 2016 granted Phelimin an Orphan Drug Designation. EU orphan designation number: EU/3/16/1784
The Decision is published for information in all official languages of the EU in the Community Register of Orphan Medicinal Products (http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2016/12/human_orphan_001874.jsp&mid=WC0b01ac058001d12b).
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 represent MipSalus.
Promising results with breakthrough treatment of orphan disease PKU
March 2016: Studies evidence MipSalus’ technology in PKU animal model: MipSalus’ MIP-based product reduces the blood Phe level by approx. 70% in mice fed with high-protein. The studies have been conducted with Phe levels that are clinically relevant if proportionally scaled up to humans.
Grant for feasibility study of home sensor
February 2016: MipSalus receives a DKK 0.5 million grant from Innovation Fund Denmark for a feasibility study of its home sensor for blood phenylalanine. Intended to establish all technical aspects, the study is an important step prior to the development of a proto type.
Grant for development of breakthrough treatment of PKU
February 2014: MipSalus receives a DKK 13 million grant from Højteknologifonden (now: Innovation Fund Denmark) for the development of the company’s breakthrough treatment of the orphan disease Phenylketonuria (PKU) in close collaboration with Aarhus University, Denmark.