FREIBURG, Germany, May 04, 2015
Today, Greenovation Biotech GmbH filed a phase I clinical trial application (CTA) for its drug candidate moss- a -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 a-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 a-galactosidase, so called enzyme replacement therapy (ERT).
About Greenovation Biotech GmbH
Greenovation develops next generation biopharmaceuticals in particular in rare disease indications. Human a -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.
Contact and further information:
Greenovation Biotech GmbH
Manon Bartusel, Tel. +49 761 470 99 0
e-mail: mbartusel@greenovation.com
web: www.greenovation.com
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Today, Greenovation Biotech GmbH filed a phase I clinical trial application (CTA) for its drug candidate moss- a -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 a-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 a-galactosidase, so called enzyme replacement therapy (ERT).
About Greenovation Biotech GmbH
Greenovation develops next generation biopharmaceuticals in particular in rare disease indications. Human a -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.
Contact and further information:
Greenovation Biotech GmbH
Manon Bartusel, Tel. +49 761 470 99 0
e-mail: mbartusel@greenovation.com
web: www.greenovation.com
Help employers find you! Check out all the jobs and post your resume.
