Rhythm will use Camurus' drug delivery technology, FluidCrystal®, to formulate its once-weekly obesity drug candidate, setmelanotide (RM-493), then develop, manufacture, and commercialize the new formulation under a license agreement disclosed by the companies today.
The agreement could generate up to $65 million for Camurus, consisting of an upfront payment and progressive payments, the majority of which are tied to achieving sales milestones. Camurus is also eligible to receive tiered, mid to mid-high, single digit royalties on future sales of the product.
The companies have collaborated to develop the formulation, designed to allow once-weekly injection of setmelanotide. Rhythm plans to initiate a Phase I clinical trial with the setmelanotide FluidCrystal formulation after completing GMP manufacturing.
“We believe this new formulation will provide a significant benefit to patients, improving compliance and ease of use with once-weekly dosing,” Rhythm president Bart Henderson said in a statement.
Under the license agreement, Rhythm is responsible for manufacturing, development, and commercialization of the setmelanotide FluidCrystal formulation worldwide.
Setmelanotide is a melanocortin-4 receptor (MC4R) agonist designed to treat obesity caused by genetic deficiencies in the MC4 pathway. A Phase II setmelanotide trial is ongoing for the treatment of Prader-Willi syndrome, a rare genetic disorder that causes life-threatening obesity. A second Phase II trial is ongoing for the treatment of pro-opiomelanocortin deficiency obesity.