LG Chem's Oral Rare Obesity Drug Shows Positive Signal for Advancing to Phase 3 Clinical Trial

Similar Efficacy Trends Observed

Rhythm Pharmaceuticals, a U.S.-based company that has licensed the global rights to the oral rare obesity drug candidate 'Vibamelagon' from LG Chem, announced topline results from its Phase 2 clinical trial for hypothalamic obesity on July 9 (local time).

LG Chem

According to Rhythm Pharmaceuticals, the clinical results for Vibamelagon, which is being developed as an oral therapy, showed a trend similar to the efficacy results observed in previous clinical trials of its injectable treatment, 'Setmelanotide.'

Since July last year, Rhythm Pharmaceuticals recruited 28 patients aged 12 or older with hypothalamic obesity, who have difficulty controlling appetite due to hypothalamic dysfunction, and evaluated changes in body mass index (BMI) at the 14-week mark of drug administration.

In the high-dose group (600mg), BMI decreased by 9.3 percentage points after 14 weeks of administration. In the mid-dose group (400mg), BMI decreased by 7.7 percentage points, and in the low-dose group (200mg), BMI decreased by 2.7 percentage points. In the placebo group, BMI increased by 2.2 percentage points. The trial demonstrated favorable safety and tolerability results, with the most commonly reported adverse events being diarrhea and nausea, most of which were mild.

Rhythm Pharmaceuticals plans to hold regulatory advisory meetings with authorities in the United States and Europe regarding clinical trial approval, including the design of the Phase 3 trial. The company also intends to conduct formulation improvement studies for Vibamelagon. In addition, it will present the results of this clinical trial at the Endocrine Society Annual Meeting in San Francisco, United States, on July 12.

Vibamelagon is a satiety signal gene agonist independently developed by LG Chem and globally licensed to Rhythm Pharmaceuticals in January last year. Of the $100 million received as an upfront payment, $40 million will be reflected in the company's performance for the third quarter. LG Chem may also receive milestone payments for future marketing approval and commercialization stages, as well as separate royalties based on sales.

David Meeker, CEO of Rhythm Pharmaceuticals, stated, "These results suggest the potential of Vibamelagon as a treatment for patients with hypothalamic obesity and are positive in that they establish an appropriate dosage range. We will work with regulatory authorities in the United States and Europe to discuss and establish the design for the Phase 3 trial of Vibamelagon."

Son Jiwoong, Head of Life Sciences at LG Chem, said, "Currently, due to limited treatment options in the rare obesity field, there is a growing demand for more convenient and effective therapies. We will actively support Vibamelagon so that it can provide a better life for patients with rare obesity."