Greenovation Biotech GmbH, the developer of BryoTechnology, a biopharmaceutical manufacturing technology based on moss-plants, announced opening of an additional clinical study center in Hungary for its moss-aGal phase I clinical trial. As a clinical stage biopharmaceutical company Greenovation exploits its proprietary Bryotechnology to produce highly-efficient glycoproteins for the treatment of orphan diseases.
Greenovation Biotech GmbH receives authorization to start phase I clinical trial for its moss-aGal development in Hungary. Study center will be at the Semmelweis Universtity, Faculty of Medicine, II. Pediatric Clinic, Prof. Fekete, in Budapest.
Recruitment in the trial is underway: In Germany, the first three Fabry patients received a single dose of moss-aGal. No side effects have been reported. Morbus Fabry is a metabolic disease belonging to the group of inherited lysosomal storage diseases. The study with 6 patients is expected to be completed in 2017.
Moss-aGal, a recombinant form of human alpha-galactosidase, has been developed by Greenovation as an enzyme replacement therapy (ERT) to treat Fabry patients. In the phase 1 study safety, pharmacokinetics and efficacy of moss-aGal will be evaluated.
“The clinical study is progressing. Three patients have been treated and moss-aGal was well tolerated. With the inclusion of the clinical trial site in Hungary we will be able to complete the study in 2017. People with Fabry’s disease often do not have access to treatment. We hope to improve with our development the situation for patients.” says Dr. Thomas Frischmuth, CEO of Greenovation.