LG CHEM announced on the 10th that it has confirmed the efficacy of the oral rare obesity drug candidate 'Bivamelagon' in Phase 2 trials conducted by its U.S. partner. Based on this, the company plans to proceed with Phase 3 clinical trials in the U.S. and Europe.
According to the company, the U.S. partner Rhythm Pharmaceuticals announced the Phase 2 clinical results for hypothalamic obesity on the 9th (local time), finding a similar trend to the efficacy results from past clinical trials of 'Setmelanotide', a treatment administered via injection. The company is scheduled to present these results at the Endocrine Society meeting (ENDO) in San Francisco on the 12th.
Rhythm evaluated body mass index (BMI) changes at week 14 of treatment in 28 patients aged 12 and older with hypothalamic obesity, who have experienced impaired hypothalamic function leading to appetite control difficulties since last July. As a result, BMI decreased in all dose groups compared to the placebo group, with good safety and tolerability, and the most common adverse events were diarrhea and nausea, most of which were mild.
Based on these results, the company plans to conduct advisory meetings related to clinical approval and clinical trial design with regulatory authorities in the U.S. and Europe, as well as research on formulation improvements for Bivamelagon.
Bivamelagon is an 'MC4R agonist', a gene developed by LG CHEM that sends signals of satiety. It is a new drug substance for patients with rare obesity caused by abnormalities in the MC4R signaling pathway that prevent proper appetite control, and the overseas development and sales rights were transferred to Rhythm in January of last year. At that time, LG CHEM received $100 million (approximately 137.2 billion won) as an advance payment.
LG CHEM may receive milestone payments and separate royalties based on sales, depending on the approval and commercialization of the sales permissions.
David Meeker, CEO of Rhythm Pharmaceuticals, noted, "These results suggest the potential for Bivamelagon in treating hypothalamic obesity patients and establish an appropriate dosage range, which is positive."
Son Ji-woong, head of the life sciences division at LG CHEM, said, "Currently, treatment options in the field of rare obesity are limited, leading to increased demand for more convenient and effective treatments," adding, "We will actively support Bivamelagon to provide a better life for patients with rare obesity."