LG Chem Accelerates Development of New Obesity Treatment Drug
2020-09-28 · LG Life Sciences · original lgchem.com ↗
LG Chem Accelerates Development of New Obesity Treatment Drug ■ Clinical first phase new obesity drug project receives US FDA orphan drug designation - Expected to raise commercial value with benefits such as market monopoly rights to protect against entry of follow-up drugs ■ Developed first orally administrated treatment among MC4R (appetite control protein) ■ The rare obesity treatment market of the US expected to grow to 1 trillion KRW by '27 LG Chem will begin its challenge in earnest in the US rare obesity treatment market that is expected to grow to worth 1 trillion KRW by 2027. Regarding this, LG Chem announced that it received orphan drug designation as a genetic obesity treatment from the US Food & Drug Administration (FDA) for the new drug project ‘LG54640’ that is currently in clinical stage 1 in the US. Orphan drug designation is a system that offers various benefits to drug development companies to encourage them to develop treatment for incurable diseases or life-threatening diseases that have few patients, and therefore, little market incentive. Benefits include clinical test subsidies, tax deductions, exemption from sales approval review expenses, and monopoly status in the market. In particular, after receiving approval for sales, it can stop entry of similar follow-up drugs with exclusive sales right in the US, and therefore, the potential business value of the new drug can also be expected to increase. ‘LB54640’ is an orally administered obesity treatment with a new mechanism that targets MC4R, which is a type of G protein combined receptor. If there is an irregularity with the MC4R action route, obesity resulting from compulsive overeating due to continued hunger can worsen and even be life-threatening. LG Chem confirmed in the pre-clinical results of ‘LB54640’ that it is effective for not only suppressing appetite and weight-loss, but also as a safe obesity treatment without side effects on the central nervous system and cardiovascular system. Furthermore, LG Chem announced its plans to verify pharmacokinetic features suitable for daily oral administration to develop distinguished treatment with improved patient convenience through oral dosage in the obesity market that is currently comprised mainly of injection treatment. LG Chem is currently conducting clinical phase 1 studies to assess the safety of the drug for 96 general obesity patients (body mass index of 27 kg/㎡ or higher) in the US, since administering the drug to the first patient in June. Plans are to complete clinical first stage studies by the first half of 2022 and to conduct clinical phase 2 and 3 for genetic rare obesity patients simultaneously in 2022, while receiving approval for sales in 2026 with its unique clinical strategy. It also plans to expand indication from general obesity to continue to improve the value of the new drug. Jeewong Son (Executive Vice President / President, Life Sciences) said, “The US FDA Orphan Drug Designation will serve as an important milestone for LG Chem’s journey in developing new obesity treatment drugs,” and added, “We will speed up our efforts to commercialize innovative new drugs for obesity patients in which there is fierce global competition in development.” Meanwhile, according to the global market study institute EvaluatePharma, the Orphan Drug Designation in the US this year is 10 million USD (app. 11 billion KRW), but it expects the market to grow rapidly to be worth 900 million USD (app. 1 trillion KRW) in 2027 through technological development and popularization of genetic diagnosis testing technologies.
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