In October, Greenovation Biotech GmbH successfully completed the Phase I study of moss-aGal for the treatment of Fabry disease (FD). The results of the study indicate that moss-aGal has an excellent safety profile at the tested dose of 0.2 mg / kg body weight. The single-dose study was planned for patients suffering from FD. Therefore, all six participants had increased Gb3 levels in the urine due to their disease. The evaluation of the data shows a significant decrease from baseline in all six patients 14 and 28 days post dosing after a single infusion of moss-aGal. In all cases, the new drug was tolerated very well with no serious treatment emergent adverse events. The data from the study will be first publicly presented on February 8, 2018 at the 14th World SymposiumTM for Lysosomal Storage Diseases in San Diego, USA by Prof. Julia Hennermann, University Medical Center Mainz. Four of the six patients have been treated at the University Medical Center in Mainz in Germany.
“The observed drop in urine Gb3 levels clearly indicates efficient targeting of moss-aGal to patients’ kidneys, one of the most affected organs in Fabry disease.” says Prof. Julia Hennermann, Lead Investigator of the study. Greenovation Biotech GmbH has developed a process using the genetically modified moss Physcomitrella patensto produce complex human enzymes in bioreactors. Moss-aGal is a recombinant form of human alpha-galactosidase. Greenovation develops moss-aGal as enzyme replacement therapy (ERT) for patients with Fabry disease. It is the first clinical product produced in Greenovation`s moss-based manufacturing technology for biopharmaceuticals and the first drug candidate produced in moss worldwide. “We are thrilled about the great data from our study 1 on the development of moss-aGal. The plans for a clinical trial II / III are already in progress. According to our plans, we expect a market maturity at the beginning of the next decade.” says Dr. Thomas Frischmuth, Managing Director of Greenovation.