MFDS Approves Clinical Phase 1b/2 Trials

LG Chem Accelerates Clinical Development of Osteoarthritis Treatment View original image

[Asia Economy Reporter Seo So-jeong] LG Chem is officially launching clinical development for the treatment of osteoarthritis.


On the 4th, LG Chem announced that it received approval from the Korean Ministry of Food and Drug Safety for the Phase 1b/2 clinical trials of its new osteoarthritis drug candidate, 'LG34053.' Osteoarthritis is a degenerative disease that causes pain and walking difficulties due to inflammation within the joints and cartilage wear.


LG Chem plans to accelerate new drug development through a clinical trial design that links Phases 1 and 2.


Following this approval, LG Chem will conduct studies at Samsung Seoul Hospital targeting patients with mild to moderate (K&L 2~3) knee osteoarthritis to evaluate safety, tolerability, pharmacokinetics (absorption, distribution, metabolism, and excretion of the drug), efficacy, and to select the optimal dosage.


LG34053 is an injectable new drug with a novel mechanism that blocks inflammatory pathways and inhibits chondrocyte apoptosis. Preclinical results showed not only pain relief effects but also improvement in cartilage damage, the root cause of arthritis. LG Chem aims to develop this drug as a differentiated new treatment compared to existing symptomatic pain relief therapies.


To secure global clinical data, LG Chem plans to expand the Phase 1b/2 trials to Australia and subsequently conduct global Phase 3 trials in regions including the United States, aiming for full-scale global commercialization starting in 2028.


According to global market research data, the osteoarthritis market in the seven major countries with large healthcare markets?United States, Japan, Germany, France, United Kingdom, Italy, and Spain?is expected to reach a scale of 2 trillion KRW by 2028.


Son Ji-woong, Head of the Life Sciences Business Division, stated, "Entering the clinical phase for the osteoarthritis new drug is a major achievement of our company-wide efforts for R&D innovation and will be an important milestone for LG Chem's new drug business. We will provide new treatment alternatives for arthritis patients worldwide who still suffer due to limited treatment options."



He emphasized, "Based on a diverse portfolio of arthritis treatments developed in-house and through active open innovation, we will continuously increase the likelihood of success in developing innovative new drugs."


This content was produced with the assistance of AI translation services.

© The Asia Business Daily(www.asiae.co.kr). All rights reserved.

Today’s Briefing