Mike Owles

Mike Owles inquired about Rhythm Pharmaceuticals' latest thinking on the trial design for the Phase III hypothalamic obesity (HO) study for bivamelagon and any initial feedback received from the FDA.

Answer

David Meeker, Chairman, CEO and President, Rhythm Pharmaceuticals, explained that the HO trial design for bivamelagon would be similar to previous MC4R pathway trials, likely a double-blind randomized controlled trial with a full year of data expected by regulators. He noted that the primary endpoint would be percent BMI change, enrolling children and adults. Feedback from the FDA is anticipated in Q1 next year during a post-Phase II meeting.

Mike Owles asked about the latest thinking on the trial design for Rhythm Pharmaceuticals' phase three hypothalamic obesity (HO) study for bivamelagon and any initial feedback received from the FDA.

Answer

David Meeker, Chairman, CEO and President, explained that the HO trial for bivamelagon would be a double-blind, randomized controlled trial, similar to previous MC4R pathway studies, focusing on BMI % change in children and adults. He noted that the FDA would likely want a full year of data, potentially a six-month double-blind period followed by six months open-label. He anticipates receiving FDA feedback during a post-phase two meeting in the first quarter of next year.