Rhythm expects to achieve the following near-term milestones: Present data analysis from the Phase 2 and long-term extension trials in hypothalamic obesity at a medical conference in the fall of 2023; Announce preliminary data from the open-label part of the Phase 2 DAYBREAK trial from one or more genetically-defined cohorts in the second half of 2023; Announce topline data from the ongoing Phase 3, open-label pediatrics trial evaluating one year of setmelanotide therapy in patients with MC4R pathway deficiencies between the ages of 2 and 6 years old in the second half of 2023; Provide pharmacokinetic and tolerability data from the ongoing Phase 3 switch trial evaluating a weekly formulation of setmelanotide in the second half of 2023; Complete patient enrollment in the pivotal Phase 3 clinical trial in hypothalamic obesity in the fourth quarter of 2023; Provide an update on pre-clinical development programs, including RM-718 and the Company’s congenital hyperinsulinism program, in the fourth quarter of 2023; and Initiate a Phase 3, randomized, double-blind trial in patients naive to setmelanotide therapy to evaluate the weekly formulation of setmelanotide in patients with BBS in 2024.
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