Submission of Opinion Letter to AMED, MHLW, PMDA, etc.

On August 17th, 2025, Triplex Therapeutics Inc. (CEO: Dr. Takamitsu Yano) officially submitted opinion statements addressing serious concerns regarding the safety, efficacy, and clinical relevance of experimental PI polyamides. These molecules, designed by a third-party group to bind the A3243G mutant mitochondrial DNA and inhibit its replication, stand in contrast to our ML1 polyamide, which binds to normal mitochondrial DNA and promotes replication.

The opinion letters and supplementary documents were formally submitted to:

– Japan Agency for Medical Research and Development (AMED)
– Ministry of Health, Labour and Welfare (MHLW), Division of Research and Development Promotion
– Pharmaceuticals and Medical Devices Agency (PMDA)
– Japanese Society for Mitochondrial Research and Medicine (J-mit 24th Annual Meeting Secretariat)

All documents were submitted via both e-mail and registered postal mail.
Every step we take is guided by our mission to protect the lives and futures of patients and their families.

Triplex Therapeutics remains committed to prioritizing patient safety in mitochondrial diseases such as MELAS, and to advancing therapeutic strategies based on rigorous scientific validation.