Camurus (STO:CAMX) and biopharma group Rhythm today released initial results from an ongoing Phase 1A clinical trial examining the pharmacokinetics and tolerability of an extended-release formulation of setmelanotide.
The drug formulation uses Camurus’ FluidCrystal injection depot drug delivery technology to deliver Setmelanotide, Rhythm’s novel melanocortin-4 receptor agonist designed to treat genetic disorders of obesity.
Initial results from the ongoing double-blind, placebo-controlled, single-rising-dose study met the trial’s pharmacokinetics and tolerability criteria, according to a press release.
“The initial results from this first trial are impressive and meet our pharmacokinetics and tolerability criteria for a once-weekly formulation of setmelanotide. We intend to develop this once-weekly formulation as a product line extension, to improve convenience for patients with genetic deficiencies in the MC4 pathway,” Rhythm CEO Dr. Keith Gottesdiener said in a prepared statement.
The FDA has granted setmelanotide a breakthrough therapy designation for treating pro-opiomelancortin and leptin receptor deficiency obesity, the company said.
“Reducing the burden of daily injections, and thereby contributing to keeping the individual at a healthy weight, is an important step forward that may potentially provide patients with enhanced quality of life,” Camurus prez & CEO Dr. Fredrik Tiberg said in a press release.
Results from Phase 2 clinical trials demonstrated significant weight loss and reductions in hunger in those patients, the companies said. A phase 3 trial for the drug has recently been initiated, the companies added.