Recent scientific evidence implicates defects in the MC4 pathway as the likely cause of the weight and appetite abnormalities in PWS. A Phase 2 setmelanotide trial is ongoing for the treatment of Prader-Willi syndrome (PWS), a rare genetic disorder that causes life-threatening obesity. The critical role of the MC4 pathway in weight regulation was validated with the discovery that single genetic defects along this pathway result in early-onset and severe obesity. Setmelanotide is a potent, first-in-class MC4R agonist in development for the treatment of obesity caused by genetic deficiencies in the MC4 pathway, a key pathway in humans that regulates energy expenditure, homeostasis, and appetite. In addition, Camurus is eligible to receive tiered, mid to mid-high, single digit royalties on future sales of the product. Camurus is eligible to receive an upfront payment and progressive payments of approximately $65 million, of which the majority are sales milestones. Under the terms of the license agreement, Rhythm is responsible for manufacturing, development, and commercialization of the setmelanotide FluidCrystal formulation worldwide. The formulation has been developed in a collaboration between the companies. The license granted to Rhythm is specific to the FluidCrystal technology incorporating setmelanotide. "Rhythm's setmelanotide represents a novel approach to treating patients suffering from life-threatening obesity due to these rare and serious genetic disorders." ![]() "The partnership with Rhythm follows the formulation development and preclinical assessment of this compelling drug candidate based on our FluidCrystal Injection depot technology," said Fredrik Tiberg, President and CEO of Camurus. "We believe this new formulation will provide a significant benefit to patients, improving compliance and ease of use with once-weekly dosing." ![]() ![]() "We have developed a setmelanotide formulation with Camurus with an impressive sustained-duration profile," said Bart Henderson, President of Rhythm. Rhythm plans to initiate a Phase I clinical trial with the setmelanotide FluidCrystal formulation after completing GMP manufacturing. Under the terms of the agreement, Camurus has granted Rhythm a worldwide license to the FluidCrystal technology to formulate setmelanotide and to develop, manufacture, and commercialize this new formulation that has the potential for once-weekly dosing, administered as a subcutaneous injection. 5, 2016 /PRNewswire/ - Rhythm and Camurus announced today a license agreement for the use of Camurus' drug delivery technology, FluidCrystal®, to formulate setmelanotide (RM-493), Rhythm's novel melanocortin-4 receptor (MC4R) agonist.
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