Greenovation filed phase I clinical trial application for its moss-aGal compound intended for treatment of patients suffering from Fabry Disease
Freiburg, Germany, May 04, 2015
Today, Greenovation Biotech GmbH filed a phase I clinical trial application (CTA) for its drug candidate moss-alpha-galactosidase (moss-aGal), a moss-made biopharmaceutical compound intended for use as enzyme replacement therapy in patients suffering from Fabry Disease. Greenovation’s moss-aGal will most likely be the first moss-made therapeutic approved for human treatment.
Moss-aGal is Greenovation’s first clinical candidate developed by using their proprietary Bryotechnology platform, which allows optimized and effective production of highly-efficient glycoproteins.
The phase I clinical trial design for moss-aGal is intended to provide safety data on the molecule as well as initial information about efficacy.
"Our vision is to provide moss-made enzymes that allow a safer and better treatment of patients suffering from rare diseases. So we are very excited to move our first drug candidate moss-aGal into phase I,” says Dr. Thomas Frischmuth, CEO of Greenovation.
About Fabry Disease
Fabry Disease is a rare genetic lysosomal storage disorder that is caused by deficient activity – subnormal or absent – of the lysosomal enzyme α-galactosidase A. Absence of the enzyme leads to progressive accumulation of glycosphingolipids, predominantly ceramide trihexoside (CTH or Gb3), in most tissues and cell types, particularly the vascular endothelial and smooth-muscle cells leading to various symptoms including excruciating pain,renal impairment and cardiomyopathy. Fabry Disease affects about 1–5 in 10,000 people worldwide. Treatment of Fabry Disease is done by regular infusion of a biotechnologically produced substitute of the missing enzyme α-galactosidase, so called enzyme replacement therapy (ERT).
About Greenovation Biotech GmbH
Greenovation develops next generation biopharmaceuticals in particular in rare disease indications. Human alpha-Galactosidase produced in moss is the company’s lead compound intended to serve as enzyme-replacement therapy (ERT) in patients suffering from Fabry Disease. Results of the recently completed pre-clinical program clearly indicate superiority of features with respect to pharmacokinetics (delayed clearance), pharmacodynamics and biodistribution. Greenovation’s development pipeline further includes glucocerebrosidase (glucerase, for ERT of Gauchers Disease), complement factor H (to treat atypical HUS), acid glucosidase (alglucerase for ERT in of Pompe Disease) and antibody (IgG) programs for enhanced ADCC.