Biomiga, a next-generation live biotherapeutic products (LBP) corporations, said on the 11th that it received U.S. Food and Drug Administration (FDA) investigational new drug (IND) approval for BM109, a candidate therapy for trimethylaminuria (TMAU), also known as fish odor syndrome.
Fish odor syndrome is a congenital rare disease in which the body cannot properly break down trimethylamine, causing a foul odor similar to fishiness in breath or sweat. It greatly affects patients' social lives and quality of life, but there is no fundamental treatment to date.
BM109 is a live biotherapeutic based on a single strain of Paracoccus aminovorans discovered in-house by Biomiga. It works by breaking down and removing trimethylamine (TMA) and trimethylamine N-oxide (TMAO), substances that cause odor in the body.
With this IND approval, Biomiga will enter phase 1/2a trials in actual TMAU patients rather than healthy adults. The trials will be led by principal investigators (PIs) from the research teams of Dr. Spencer at Yale University and Dr. Chundriess at Mayo Clinic. They will oversee patient dosing and assessments of safety and efficacy.
Previously, Biomiga completed nonclinical studies of BM109 with support from the Korea Drug Development Fund (KDDF) and received orphan drug designation (ODD) from the FDA in May last year. The U.S. clinical procedures were carried out in collaboration with KCRN Research, the contract research organization (CRO), among others.
The corporations is also seeking to expand target indications based on BM109. Through the Scale-up TIPS project of the Ministry of SMEs and Startups, it is currently pursuing FDA clinical approval procedures for an ischemic stroke indication. It plans to broaden development to cardiovascular disease (CVD) and chronic kidney disease (CKD) as well.
Yoon Sang-seon, CEO of Biomiga, said, "We are proceeding with clinical trials in actual patients together with researchers at Yale University and Mayo Clinic," and added, "This trial will accelerate not only the development of a TMAU therapy but also subsequent indications such as stroke."