The Gwangju Institute of Science and Technology (GIST) noted on the 28th that the new drug candidate 'GM-60106', developed by the faculty startup company JD BioScience, received global clinical phase 2a trial plan (IND) approval from the U.S. Food and Drug Administration (FDA).
'GM-60106' is a low molecular compound-based drug candidate under development for the treatment of metabolic-related fatty liver disease (MASH). JD BioScience is a company founded by Professor Jin-Hee Ahn of the GIST Department of Chemistry. The development has been in progress since receiving a technology transfer from GIST in 2018.
'GM-60106' can inhibit the HTR2A receptor, simultaneously preventing fatty liver accumulation and liver fibrosis. The HTR2A receptor is a type of serotonin receptor distributed in the brain and nervous system, regulating various brain functions such as emotional control, cognitive function, memory, and sleep by binding with serotonin.
JD BioScience has been preparing for clinical trials in the U.S. in collaboration with the global clinical research organization (CRO) IQVIA, starting with a pre-IND meeting with the FDA in November 2024. Following this, they submitted the clinical trial plan (IND) to the FDA on March 31 of this year and obtained phase 2a clinical trial approval on April 29.
This clinical trial is a proof-of-concept study involving 90 MASH patients. The safety, efficacy, biological activity, and pharmacokinetic properties of 'GM-60106' will be evaluated. The trial will be conducted for 12 weeks at several hospitals in the U.S. using a randomized, double-blind, placebo-controlled method.
Jin-Hee Ahn, the CEO, said, "With the approval of this phase 2a trial, we have gained more confidence in the innovation and therapeutic potential of GM-60106," adding, "We are actively pursuing cooperation with strategic partners to successfully carry out phase 2 trials."
He further added, "We are seeking various forms of partnerships, including joint development and technology transfer with pharmaceutical companies at home and abroad, aiming for rapid entry into the global market."