LG Chem's Hereditary Obesity Treatment Designated as Orphan Drug by US FDA

Challenging a 1 Trillion Won Market by 2027... Accelerating New Drug Development for Obesity Treatment

[Asia Economy Reporter Seo So-jung] LG Chem is making a full-scale challenge in the U.S. rare obesity treatment market, which is expected to grow to a scale of 1 trillion won by 2027.

LG Chem announced on the 28th that its new drug candidate 'LB54640,' currently in Phase 1 clinical trials in the U.S., has been designated as an orphan drug for hereditary obesity treatment by the U.S. Food and Drug Administration (FDA).

The orphan drug designation is a system designed to actively encourage the development of treatments for rare or life-threatening diseases with a small number of patients and limited market potential. Companies developing orphan drugs receive benefits such as clinical trial grants, tax reductions, exemption from marketing approval review fees, and market exclusivity rights. After marketing approval, they can defend market exclusivity in the U.S. for seven years against the entry of subsequent drugs in the same class.

'LB54640' is a new mechanism oral obesity treatment targeting MC4R, a type of G-protein coupled receptor. When there is an abnormality in the MC4R signaling pathway, persistent hunger leads to hyperphagia, which worsens obesity and can threaten life.

LG Chem confirmed through preclinical results that 'LB54640' not only has excellent effects in reducing appetite and body weight but also has the potential to be a safe obesity treatment without central nervous system or cardiovascular side effects. Additionally, it confirmed pharmacokinetic properties suitable for once-daily oral administration, aiming to develop a differentiated treatment that enhances patient convenience in the obesity market, which is currently centered on injectable therapies, in a timely manner.

LG Chem is currently conducting a Phase 1 clinical trial in the U.S. involving 96 general obesity patients (body mass index of 27 kg/㎡ or higher) to evaluate the drug's safety, having started dosing the first patient in June. The company plans to complete Phase 1 by the first half of 2022 and simultaneously conduct Phase 2 and 3 clinical trials targeting hereditary rare obesity patients from 2022, aiming for marketing approval in 2026. Furthermore, it plans to expand indications to general obesity to increase the value of the new drug.

Son Ji-woong, Head of the Life Sciences Business Division, said, "The FDA orphan drug designation is an important milestone in LG Chem's journey to develop a new obesity treatment drug," adding, "We will accelerate efforts to commercialize innovative new drugs in the highly competitive global obesity disease field."

Meanwhile, according to global market research firm Evaluate Pharma, the U.S. rare obesity treatment market is only about 10 million dollars (approximately 1.1 billion won) this year but is expected to expand to 900 million dollars (approximately 1 trillion won) by 2027.