Corline Biomedical AB («Corline») has been in the beslutsbrev from the Swedish medical products agency received permission to conduct a clinical trial of the drug candidate Renaparin®. Agency the permission notice means that all formal requirements are met for the implementation of the study RENAPAIR 01, which is a safety study in phase 1 comprising a total of 18 patients.
Renaparin® is under development to improve kidney transplantation and administered to the kidney prior to transplantation in order to reduce the kidney damage that may otherwise occur when the receiving the patient’s blood flow to be paired with a donor kidney. Corline announced in June 2018, for the medical products agency submitted the application for conducting clinical trial of Renaparin® in a placebo-controlled study (RENAPAIR 01, Eudra-CT 2017-002075-25) where the 9 patients transplanted with kidneys that received the active substance and 9 patients received inactive placebo. This application has now been approved by the Fda. The study in Uppsala, and will then be implemented at the transplantationsenheterna in Uppsala and Huddinge, sweden. The planned start is in the autumn of 2018.
Corline has previously announced that the Board has given its approval for the study and it is 100 % financed through the H2020 grants that the company received in 2017.
The company estimates that the market potential for Renaparin® amounts to SEK 4 billion on an annual basis for the treatment of the approximately 35 000 kidneys that are annually transplanted in the EUROPEAN union and the united states.
Henrik Nittmar, PRESIDENT of Corline Biomedical AB, comments
«We are thrilled about the positive news we have now reached! The medical products agency’s approval is the last piece of the puzzle that needed to fall into place for us to be able to start the clinical trial of Renaparin. When we are dosing the first patient goes Corline from the status that pre-clinical development company to a company in the clinical phase. It is a märkeshändelse for Corline and for all of our employees and partners who have fought for a number of years for this common goal. We see that the Renaparin has a great commercial potential and a clear development path forward and look forward with confidence to the future».
For questions, please contact
Henrik Nittmar, CEO
Telephone: 018-71 30 90
Subsequently, the Brokerage is Corlines Certified Adviser.
This information is such information that Corline Biomedical AB is obliged to publish under the EU marknadsmissbruksförordning. The information was submitted, by the above contact person in the government, for publication on 6 August 2018.
Corline Biomedical AB
working with the endogenous substance heparin and has developed a portfolio of candidate drugs for use in conjunction with organ — and cell transplantation. The company is planning clinical studies in type 1 diabetes and kidney transplant, for which the Corline also has received särläkemedelsstatus («Orphan Drug»). Within the framework of a wholly owned subsidiary of Corline Pharma AB evaluated the in vivo administration of Corlines heparinsubstans.
180806_PM — Corline — the medical products agency grants permission
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Source: Corline Biomedical AB via Globenewswire