MLD submits Pre-IND package for its RCDP orphan drug

SASKATOON, SK, CANADA. MLD, a developer of advanced plasmalogen-based therapeutic products, is pleased to announce that it has submitted its pre-Investigational New Drug (pre-IND) briefing packet to the FDA for its lead orphan compound, PPI-1040, for the treatment of Rhizomelic Chondrodysplasia Punctata (RCDP). RCDP is a highly debilitating rare paediatric genetic disorder caused by mutations in peroxisomal genes involved in plasmalogen lipid biosynthesis. The FDA has granted MLD a Type B pre-IND meeting scheduled for the last week of January, 2018.

The Pre-IND briefing packet includes information on PPI-1040, preclinical data generated to date, the GLP safety toxicology plan, natural history of the disease, and proposed clinical development path. At the meeting, MLD will be seeking guidance from the FDA on the plan, including suitability of proposed biochemical and functional endpoints.

MLD's Chief Scientific Officer and Interim CEO, Shawn Ritchie, stated, "Preparing this package has been a team effort by MLD, our consultants, and primary investigator. We are very pleased to have an opportunity to visit the FDA in the New Year, and look forward to a constructive meeting. This is a significant milestone in the development of a putative treatment for RCDP, for which there are currently no treatment options."

About MLD

MLD is a Canadian health prevention company developing novel plasmalogen replacement compounds for the treatment of various disorders associated with plasmalogen deficiency, including RCDP, Alzheimer's disease, Parkinson's disease, and Multiple Sclerosis, as well as companion screening tests that detect metabolic risk for chronic diseases including neurodegenerative disorders and cancer.

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