Zymenex has – with the financial support of BankInvest Biomedical Venture and Sunstone Capital – achieved successful early clinical development of a therapeutic candidate Metazym against the rare, lethal and genetically caused, disease MLD, which most often affects children at a very young age. This has now resulted in a sale of the therapeutic project to the global specialty biopharmaceutical company Shire plc.
The FDA has granted Zymenex Orphan Designation for its enzyme Metazym, for the treatment of the rare, lysosomal disease Metachromatic Leukodystropht (MLD).
Orphan designation qualifies the sponsor of the product for tax credits and marketing exclusivity inventives of the Orphan Drug Act.
Zymenex has received FDA approval of its Investigational New Drug (IND) application for its enzyme Metazym, which is intended for use in the treatment of the rare, lysosomal disease Metachromatic Leukodystrophy (MLD). The company is now preparing for Phase 2 clinical trials in the USA.
COPENHAGEN – The investments are key links in Sunstone Capital’s strategy to help strengthen growth potential for established biotech firms in the Oresund Region. Sunstone has done this by contributing its own money as well as by raising capital from local and international investors.
NsGene A/S announced today that its Clinical Trial Application (CTA) to start a phase Ib study of NsG0202 for Alzheimer’s disease (AD) has been approved by the Swedish Medical Products Agency (MPA).