Greenovation Announces First Patient Dosed in Phase 1b Study with Moss-aGal
FREIBURG, Germany, March 15, 2017
Greenovation Biotech GmbH announced today that it has dosed the first patient in a phase 1b study of its lead biopharmaceutical, moss-aGal, in adults with the inherited disorder, Fabry disease.
Moss-aGal, a recombinant form of human alpha-galactosidase, has been developed by Greenovation as an enzyme replacement therapy (ERT) for patients with Fabry disease, a genetic lysosomal storage disorder.
The phase 1b study, a single dose clinical trial, will assess the safety, pharmacokinetics and efficacy of moss-aGal on lyso-Gb3 levels in plasma and urine. The open-label, multicenter study is being conducted in Germany.
"The first patient who received our drug moss-aGal tolerated the drug very well“ announces Thomas Frischmuth, PhD, CEO of Greenovation. “We are thrilled to see that our first moss-made biopharmaceutical is now in clinical testing and might potentially help improve patient’s quality of life in the future. This phase 1b study, which is the first clinical trial for Greenovation, represents a major milestone for the company and hopefully for Fabry patients.”
About the study:
About Fabry disease
Fabry disease, a rare lysosomal storage disease, is caused by an inborn deficiency of the alpha-galactosidase (aGal) enzyme. A lysosomal enzyme, aGal breaks down a specific fatty acid, globotriaosylceramide (Gb3). In patients with Fabry disease, absence of aGal causes continuous accumulation of Gb3 in the cells. Symptoms include pain, and heart, skin and kidney complications, and can lead to organ failure. In enzyme replacement therapy, the missing enzyme is replaced with regular intravenous administrations of a biopharmaceutically-produced substitute.
About Greenovation Biotech GmbH
Greenovation develops next-generation therapeutics for the treatment of rare diseases.
Greenovation is a privately owned biopharmaceutical company based in Heilbronn, Germany. It was founded in 1999 by Prof. Dr. Ralf Reski and Prof. Dr. Gunter Neuhaus. Today, Greenovation Biotech GmbH is majority-owned by Zukunftsfonds Heilbronn and L-EigenkapitalAgentur (Karlsruhe).