D&D Pharmatech's New Drug Candidate Approved for Phase 2 Clinical Trial in Multiple Sclerosis in the U.S.

The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for the Phase 2 clinical trial of "NLY01," a new drug candidate being developed by D&D Pharmatech, aimed at treating multiple sclerosis.

The upcoming trial will involve 240 patients aged 18 to 60 with multiple sclerosis to evaluate the treatment's efficacy. This investigator-initiated trial will be conducted by a research team led by Professor Ellen Mowry at the Johns Hopkins School of Medicine's Multiple Sclerosis Center.

NLY01 is a drug candidate that inhibits neuroinflammation, known to be a primary cause of neurodegenerative diseases, and protects nerve cells. Previously, it demonstrated therapeutic effects in a Phase 2 clinical trial involving 255 Parkinson's disease patients in the U.S. and North America. Following these trials, a study by the Johns Hopkins research team revealed that NLY01 significantly slowed the progression of multiple sclerosis in animal models, suggesting the potential to expand its indications.

The primary objective of this clinical trial is to determine whether NLY01 can meaningfully reduce neurodegeneration-related imaging markers in patients with multiple sclerosis.

D&D Pharmatech noted that global organizations focused on finding treatments for multiple sclerosis have shown interest in this trial. The International Progressive MS Alliance, a nonprofit organization, is considering funding, and the NIH's NeuroNEXT network, which supports clinical research in neurological disorders, is also preparing a funding program.

Lee SeulKi, CEO of D&D Pharmatech, stated, "This IND approval is based on the disease-modifying therapeutic effects observed in younger patients under 60 during the previous Phase 2 Parkinson's disease trial. We plan to initiate global licensing efforts based on the diverse ongoing clinical trial results."