US-based Rhythm has entered a licence agreement to use Swedish firm Camurus’s drug delivery technology, FluidCrystal, to formulate its new melanocortin-4 receptor (MC4R) agonist, setmelanotide (RM-493).
The US firm now has worldwide licence to the FluidCrystal technology to formulate setmelanotide, as well as develop, manufacture and commercialise the new formulation with the potential for once-weekly dosing, administered as a subcutaneous injection.
Following completion of the GMP manufacturing, Rhythm intends to start a Phase I clinical trial with the setmelanotide FluidCrystal formulation.
Setmelanotide is being developed to treat obesity caused by genetic deficiencies in the MC4 pathway, a key pathway in humans that regulates energy expenditure, homeostasis and appetite.
Rhythm president Bart Henderson said: "We have developed a setmelanotide formulation with Camurus with an impressive sustained-duration profile.
"We believe this new formulation will provide a significant benefit to patients, improving compliance and ease-of-use with once-weekly dosing."
The setmelanotide FluidCrystal formulation has been developed in collaboration between the companies.
As part of the deal, Rhythm will manufacture, develop and commercialise the setmelanotide FluidCrystal formulation across the world, while Camurus will receive an upfront payment and progressive payments of about $65m, of which the majority are sales milestones.
In addition, Camurus is eligible to receive tiered, mid to mid-high, single digit royalties on future sales of the product.
Currently, a Phase II setmelanotide trial is being carried out for the treatment of Prader-Willi syndrome (PWS), a rare genetic disorder that causes life-threatening obesity.
It is reported that a second Phase II trial is ongoing to treat pro-opiomelanocortin (POMC) deficiency obesity, a very rare, life-threatening genetic disorder of the MC4 pathway associated with unrelenting appetite and obesity.
Camurus’s FluidCrystal Injection depot delivers therapeutic levels of drug substance over extended periods from a single injection.
Image: The setmelanotide FluidCrystal formulation has been developed in collaboration between Rhythm and Camurus. Photo: courtesy of Baitong333/ FreeDigitalPhotos.net.