Dimerix Limited confirmed that the US Food and Drug Administration (FDA) met with Dimerix for a Pre-Investigational New Drug (pre-IND) meeting. At the pre-IND meeting, the FDA reviewed a dossier that summarised Dimerix' proposed Phase 3 clinical program for Focal Segmental Glomerulosclerosis (FSGS) and its supporting data in the form of non-clinical studies, the manufacturing and process controls and existing Phase 1 and Phase 2 clinical data accumulated to date. Importantly, the meeting provided clarity on the remaining development of DMX-200 for FSGS through to market approval, including confirmation of endpoints for accelerated marketing approval, and the requirement for a single Phase 3 study. The agency also confirmed the proposed non-clinical package and proposed specifications for the pharmaceutical-grade drug manufactured by Dimerix are appropriate for registration of DMX-200. Focal Segmental Glomerulosclerosis is a serious and rare disease that attacks the kidney's filtering units (glomeruli) causing scarring of the tissues, leading to permanent kidney damage and kidney failure. FSGS affects both children and adults. There are no treatments currently approved for the treatment of FSGS and thus there is a strong unmet medical need. Dimerix has received Orphan Drug Designation for DMX-200 in both the US and Europe for the treatment of FSGS. Dimerix established with the respective regulatory agencies that "the intention to treat FSGS with DMX-200 was justified based on preliminary non-clinical data which showed a reduction in the number of podocytes lost and an improvement in proteinuria." Furthermore, as stated by the respective regulatory agencies, the orphan designation indicates that "Dimerix has provided sufficient justification that if approved, [DMX-200] is likely to be of significant benefit to those affected by the condition" and that "[DMX-200] would provide a clinically relevant advantage as an alternative to any currently marketed products". Orphan designation also provides regulatory and financial benefits to help bring DMX-200 to market in the US and Europe faster, including reduced fees during the product development phase, protocol assistance from the regulatory authorities, and 7-year (US) and 10-year (Europe) market exclusivity following product approval.