Greenovation successfully completes preclinical toxicology studies of alpha–galactosidase
Freiburg, Germany, March 09, 2015
Greenovation Biotech GmbH has successfully completed GLP toxicology studies in non-human primates, and has demonstrated that the moss-aGal (Agalsidase) is safe and very well-tolerated in repeated high dose administrations. The plant-based cGMP manufacturing process resulted in a high yield batch of moss-aGal to be used in upcoming clinical trials.
The GLP toxicology studies in non-human primates demonstrate the moss-aGal to be safe and well tolerated at a dose of 5 to 10 fold higher than the expected human therapeutic dose. In summary, the study investigated intravenous administration of moss-aGal via two 40-minute infusions at doses of either 0 or 5 mg/kg to male and female cynomolgus monkeys. As a result, the study concludes that moss-aGal was very well tolerated under the given study conditions and did not reveal any treatment-related findings. Thus, the no-observed-adverse-effect-level (NOAEL) is considered to be the tested dose level of 5 mg/kg.
“The successful cGMP manufacturing of moss-aGal in the moss expression plattform and the successfully concluded toxicology studies are major developmental milestones for Greenovations alpha-Galactosidase program. Currently we are working on our regulatory package for a Phase I/II clinical trial which includes Fabry Disease patients,“ stated Dr. Thomas Frischmuth, CEO of Greenovation. “Achieving a proprietary, commercially viable manufacturing process of alpha-Galactosidase demonstrates the successful development of Greenovation into a biopharmaceutical company.”
About Greenovation Biotech GmbH
Greenovation develops next generation biopharmaceuticals in particular in rare disease indications. Human alpha-Galactosidase is the company’s lead product being developed as enzyme-replacement therapy (ERT) for Fabry Disease. Results of the recently completed pre-clinical program clearly indicate superiority features with respect to pharmacokinetics (delayed clearance), pharmacodynamics and biodistribution. A multi-center clinical Phase I/II study with this candidate will be undertaken in Europe.
Greenovation’s development pipeline further includes glucocerebrosidase (glucerase, for ERT of Gaucher’s disease), complement factor H (to treat atypical HUS), antibody (IgG) programs for enhanced ADCC as well as growth factors (FGF7/KGF, EGF, HGF) for various applications.