Rhythm announces global licensing agreement with LG Chem for LB54640

Rhythm Pharmaceuticals announced it has entered into a global licensing agreement with LG Chem for LB54640, an investigational oral small molecule melanocortin-4 receptor agonist now in Phase 2 clinical trials. In a Phase 1 trial in healthy overweight adults, LB54640 demonstrated dose-dependent weight reduction. LB54640 also demonstrated a favorable safety profile in the trial, with no changes in blood pressure or heart rate observed and no hyperpigmentation observed. In addition, LB54640 has received orphan drug designation from the U.S. Food and Drug Administration for leptin receptor deficiency and proopiomelanocortin. Under the terms of the agreement, Rhythm will assume sponsorship of two Phase 2 studies designed to evaluate weight loss efficacy, safety, tolerability and pharmacokinetics of LB54640. The SIGNAL trial is a randomized, placebo-controlled, double-blind study designed to enroll and evaluate approximately 28 patients with acquired hypothalamic obesity. The open-label, single-arm, 52-week ROUTE trial is designed to enroll five patients with POMC, LEPR, or proprotein convertase subtilisin/kexin type 1 deficiency obesity. Under the terms of the agreement, Rhythm has agreed to pay LG Chem $40 million in cash and $20 million in Rhythm equity at closing and an additional $40 million in cash 18 months after closing.