US-based Rhythm Pharmaceuticals has signed a global licensing agreement with South Korean life sciences company LG Chem for the latter’s oral MC4R agonist LB54640.

LB54640 is an investigational oral small molecule melanocortin-4 receptor (MC4R) agonist now in Phase 2 clinical trials.

As per the agreement, Rhythm will pay $20m in Rhythm shares and $40m in cash to LG Chem at closing, plus an additional $40m in cash 18 months after closing.

In addition, Rhythm has committed to providing LG Chem royalties and up to $205m if specific sales and regulatory objectives are met.

Rhythm Pharmaceuticals president and CEO David Meeker said: “We are excited to build upon the strong chemistry and early translational work performed by LG Chem, a highly regarded company with deep and broad experience and expertise in the pharmaceutical business.

“The development of an effective oral therapy for treating MC4R pathway diseases has been a major goal for the industry and the early data from LG Chem suggest they have identified a specific therapy for the MC4R without hyperpigmentation or cardiovascular side effects.”

In the Phase 1 trial, LB54640 showed dose-dependent weight reduction in healthy overweight adults along with favourable safety profile.

It has received orphan drug designation from the US Food and Drug Administration (FDA) for leptin receptor deficiency and proopiomelanocortin.

Additionally, under the agreement, Rhythm will sponsor two Phase 2 trials designed to evaluate the weight loss efficacy, safety, tolerability and pharmacokinetics of LB54640.

LG Chem Life Sciences Company president Jeewoong Son said: “Rhythm has pioneered the development and global commercialisation of the first and best-in-class therapy for patients with hyperphagia and severe obesity associated with diseases like Bardet-Biedl syndrome (BBS), hypothalamic obesity and certain genetically-defined pathway diseases.”

In a separate development, the American biopharmaceutical firm announced the completion of screening for enrolment in the pivotal, Phase 3 hypothalamic obesity trial evaluating Imcivree (setmelanotide).

The top-line study results are expected in H1 2025.