Zymenex' lead product Metazym is completing pre-clinical testing and is expected to enter Phase I/II clinical trials in the second half of 2006. MLD is a childhood disease in which myelin is broken down. The disease is caused by a deficiency of the ASA enzyme and results in irreversible neurological damage. The disease is fatal and there is no therapy available. Children with MLD are most often diagnosed at three years of age and progress within three to four years to being wheelchair-bound and then bedridden prior to death.
Zymenex has published proof-of-principle data in a disease mouse model (Hum. Mol. Gen., vol. 14, no. 9, May 1, 2005) that document that Metazym breaks down specific molecules, associated to the development of the disease, in brain- and nervous tissue. Zymenex has developed a large-scale production process to manufacture the enzyme and the company has received Orphan Drug Designation for MLD in Europe. The Phase I/II clinical trial is expected to be completed in 2007.
The Zymenex pipeline also includes Lamazym, for the treatment of the lysosomal disease Alpha-Mannosidosis. This disease is due to a deficiency of the Laman enzyme, affects approximately 500 patients world wide and the project is in late pre-clinical development. The disease is lethal and there is no therapy available today. Zymenex has over the last three years collaborated with a number of European scientific groups under a EU grant “Euraman” to develop this enzyme and has, together with this scientific group, published proof-of-principle data (Hum. Mol. Gen., vol. 13, no. 18, July 21, 2004). Zymenex and its scientific collaborators recently received a new EU grant “Hueman” of € 3.2 million, under the 6th framework, to continue developing Lamazym. Lamazym has received Orphan Drug Designation in both Europe and the US.
The company’s core knowledge is within protein technology, with expertise in molecular cloning, fermentation/purification, analytical development, preclinical and clinical testing and regulatory affairs. Zymenex has proprietary intellectual property in the field of Rare Metabolic Diseases.