MipSalus closes a private placement
January 2023: MipSalus closes a private placement from private investors.
MipSalus forms a consortium comprising three of Europe’s leading PKU clinics
January 2022: In preparation for planning and conducting the upcoming clinical trials, MipSalus has built a consortium of PKU clinics in Europe comprising Rigshospitalet in Denmark, The University Hospitals Birmingham in the United Kingdom, and The Mater Hospital in Ireland.
April 2021: Once again, MipSalus expands its premises in DTU Science Park. The expansion includes laboratories, storage capacity and an additional office. The new premises will primarily be used for establishing a facility for demonstration and documentation of scalable production methods for Phelimin.
Grant for circular economy in medicine production
March 2021: MipSalus, UltraAqua A/S and Process Design A/S have received a DKK 10 million Beacon Project grant from the Ministry of Environment and Food of Denmark’s Eco-Innovation Program, MUDP. MipSalus and its collaborators will establish a facility for demonstration and documentation of scalable production methods for Phelimin. The facility will be based on the principles of circular economy and optimize resource recycling in new Danish medicinal product production. The project builds on the results from MipSalus’ former MUDP project that was successfully concluded in 2020 and aims to demonstrate how water, chemicals, and energy used in the pharmaceutical production process can be recycled.
MipSalus closes a private placement
November 2020: MipSalus closes a private placement from private investors.
Inborn Errors of Metabolism Drug Development Conference
March 2020: CSO Klaus Gregorius will present MipSalus’ groundbreaking yet simple solution to treating PKU at the Inborn Errors of Metabolism Drug Development Conference. With the new treatment which MipSauls is currently developed, PKU patients will take the phenylalanine binding drug Phelimin before eating. As Phelimin binds phenylalanine and transports it out of the body, it enables PKU-patients to consume food high in protein. Phelimin thus transforms children and adults with PKU from patients on a strict protein-limited diet to people eating a normal diet.
At the conference, which takes place in Boston, US, over 80 inherited metabolic disease drug developers and Key Opinion Leaders will explore how key challenges prohibiting accelerated drug development are being addressed.
FDA grants Phelimin an Orphan Drug Designation
February 2020: MipSalus has reached yet another Phelimin milestone with the Orphan Drug Designation granted by U.S. Food & Drug Administration, FDA. The Orphan Drug Designation was awarded based on the scientific evidence produced by MipSalus and it entails a range of benefits that apply to all stages of the development of Phelimin. The decision is published on the FDA website.
Copenhagen Nanomedicine Day
November 2019: Attending the Copenhagen Nanomedicine Day at University of Copenhagen, CSO Klaus Gregorius will give a talk on how MipSalus uses phenylalanine-binding polymer nano-particles as a medicinal product for the treatment of PKU patients
The 33rd E.S.PKU Conference
November 2019: MipSalus attends the 33rd E.S.PKU (European Society for Phenylketonuria and Allied Disorders Treated as Phenylketonuria) conference in Izmir, Turkey. The conference assembles patients, organizations and professionals, and CSO Klaus Gregorius will give a presentation on MipSalus´ breakthrough treatment of PKU and the progression of the drug development process.
Expansion of working facilities
October 2019: MipSalus increases its facilities at DTU Science Park (previously Scion DTU) including a new laboratory and extra office space for the company´s latest employees.
MipSalus closes a private placement
July 2019: MipSalus closes a private placement from private investors.
MipSalus receives a grant to develop a treatment for AKU
March 2019: MipSalus has received a DKK 0.5 million grant from Innovation Fund Denmark to develop a treatment for the ultra rare genetic disease Alkaptonuria (AKU), also known as Black Bone Disease. People affected by AKU lacks enough functional level of the enzyme required to break down homogentisic acid. Over time, the accumulation of homogentisic acid in the body leads to black and brittle bones and cartilage, and early onset osteoarthritis.
The first known medicinal treatment for AKU, nitisinone, leads to condition called nitisinone-induced hypertyrosinaemia, meaning that nitosinone causes the build-up of the amino acid tyrosine in the blood system. As a consequence of the accumulation of tyrosine, AKU patients face the same health problems as PKU patients and must thus follow a heavily protein-reduced diet. The treatment which MipSalus aims to develop will allow nitisinone-treated AKU patients to consume normal diet.
MipSalus selected for a grant for resource recycling in medicine production
November 2018: MipSalus has received a DKK 3 million grant from the Ministry of Environment and Food of Denmark’s Eco-Innovation Program, MUDP. The grant will be used to develop a concept for optimization of resource recycling in new Danish medicinal product production. MipSalus’ project aims at integrating the recycling of water, chemicals and energy in the final design of the production process of Phelimin.
Grant for resource recycling in medicine production
November 2018: MipSalus has received a DKK 3 million grant from the Ministry of Environment and Food of Denmark’s program MUDP for the developing of a concept for optimization of resource recycling in new Danish medicinal product production – “Circular by design”. The project aims at integrating the recycling of water, chemicals and energy in the final design of the production process.
MipSalus participates at the 10th International Workshop on AKU
April 2018: At the 10th International Workshop on Alkaptonuria (AKU) in Liverpool, Klaus Gregorius presented MipSalus´ new treatment principle for phenylketonuria and similar metabolic diseases such as Alkaptunoria (AKU) and Hereditary Tyrosinemia type 1 (HT1).
Collaboration with Liverpool University and The Royal Liverpool University Hospital
September 2017: Together with Liverpool University and The Royal Liverpool University Hospital, Mipsalus has conducted a series of mice studies which indicate that Phelimin can very likely be used to treat children and adolescents suffering from Alkaptunoria (AKU) – a rare inborn error of amino acid metabolism similar to PKU. The studies also suggest that Phelimin could potentially be used to lessen serious side effects resulting from the current treatment of adult AKU patients. Furthermore, results from the studies also suggest that Phelimin can be used to treat yet another inborn error of amino acid metabolism called Tyrosinemia type1 (HT-1).
Promising Results from Preliminary Safety Study
July 2017: MipSalus has conducted a preliminary 2-week safety study. By oral administration, four groups of five BALB/c mice each were given MIPs particles three times a day for both one and two weeks. No difference was observed between the treated and the 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 (TNF) in blood was measured by ELISA methods after one and two weeks.
The results confirm the assumption that both the polymer of which Phelimin is made and the particles themselves behave inert in the mouse gastrointestinal tract when dosed at a level suitable to prevent accumulation of phenylalanine from a normal diet in a PKU mouse.
Multi-dose studies with Phelimin show high efficacy and flexibility
April 2017: Mipsalus has concluded a series of multi-dose studies documenting Phelimin to be very effective in regulating phenylalanine uptake from dietary proteins. Over the course of two days, mice with PKU were treated 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 reduce and stabilize the blood phenylalanine at a normal, low level. The control group, which received dietary proteins but no Phelimin, had a significant accumulation of phenylalanine in their blood over the course of the two days the studies lasted.
The studies thus document a strong Phelimin dose-response effect, meaning that the phenylalanine uptake can be regulated at the individual meal-level. Hence, patients can regulate their blood phenylalanine very efficiently by dosing Phelimin according to each meal, which then gives them the freedom to eat many smaller meals or a few large meals of normal food.
Correction of information published on GeneFo’s website
April 2017: On April 14, GeneFo announced that MipSalus’ upcoming medicinal product Phelimin for treatment of PKU had been approved by EU authorities and awaited approval in US. This is not correct and GeneFo has removed the information from their website. It is, however, true that preclinical studies with Phelimin has been very promising and we expect to initiate clinical trials within 24 months.
Following GeneFo’s publication, MipSalus received numerous inquiries from patients and PKU associations who were all of the impression that a Phelimin treatment was now available. We highly appreciate the PKU patients’ interest in Phelimin and regard the interest as an additional confirmation of the de facto unmet medical need existing for PKU patients. It encourages us to work even harder to transform the very promising preclinical data into clinical trials..
MipSalus to collaborate with at Liverpool University
February 2017: CEO Nicolas Krogh and CSO Klaus Gregorius visited Liverpool University to meet with a research group dedicated to the study of alkaptonuria (AKU), a rare inborn error of amino acid metabolism similar to PKU. The research group has been selected for a EU grant of GBP 8 mio.
MipSalus presented the result of its studies with Phelimin and PKU, and the research group concluded that Phelimin could likely be used to treat AKU patients. To test this hypothesis, MipSalus and Liverpool University made an agreement to conduct an animal study.
MipSalus documents proof of concept for its Home Sensor
February 2017: As the results of a feasibility study, MipSalus has now gotten in-vitro proof of concept for the home sensor which will allow PKU patients to monitor the concentration of blood phenylalanine. To further develop the home sensor, additional investments are needed and we will work identifying relevant investors.
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.
MipSalus receives a grant to develop a breakthrough treatment of PKU
February 2014: Højteknologifonden (now: Innovation Fund Denmark) has selected MipSalus for a DKK 13 million grant. With the grant, MipSalus will continue the development of the company’s breakthrough treatment for the orphan disease Phenylketonuria (PKU) in close collaboration with Aarhus University, Denmark.