Relamorelin: Ghrelin Peptide Agonist
A new drug class for the treatment of GI functional disorders
Motus’ lead product candidate, relamorelin, is a potent, best-in-class, Phase 2 ghrelin agonist in development for the treatment of diabetic gastroparesis (a GI complication of diabetes) and other GI functional disorders. Relamorelin targets the receptor for ghrelin, which is a naturally occurring hormone that plays a critical role in GI motility, digestion, and the absorption of nutrients.
Prior drugs targeted the same GI motility disorders, primarily through either the serotonin or dopamine receptors, but had significant safety issues. First-generation ghrelin agonists were small molecules with limited potency and efficacy. In contrast, Motus’ relamorelin peptide retains the specificity and functionality of the naturally occurring ghrelin peptide and is designed to increase GI motility, with markedly greater potency than both naturally occurring ghrelin and the first-generation small molecule agonists of ghrelin.
Based on the promising clinical results to date of relamorelin in diabetic gastroparesis and chronic constipation, we believe this product candidate is well positioned to significantly improve the treatment of these indications.
Development Stage
As part of our clinical program, we have treated approximately 260 subjects and patients with relamorelin, which is administered by subcutaneous injection. We have completed a Phase 2 clinical trial of relamorelin in diabetic gastroparesis, and a Phase 2b clinical trial is now under way in diabetic gastroparesis. The data from the completed Phase 2 clinical trial in diabetic gastroparesis demonstrated statistically significant improvements in vomiting symptoms, and in a focused subgroup, relamorelin also showed statistically significant improvements in the other symptoms of gastroparesis. Our clinical trials also showed relamorelin to be generally well tolerated. Relamorelin has demonstrated an ability to accelerate both stomach emptying, which is important for the diabetic gastroparesis indication, and small bowel and colonic motility, which is important for lower GI indications, supporting the theory that relamorelin has effects on GI motility across the whole GI tract.
We have also completed a Phase 2a benchmark clinical trial in patients with chronic constipation, and we are conducting a Phase 2a clinical trial for refractory chronic constipation in Parkinson’s disease patients. The FDA has granted Fast Track designation to relamorelin for the treatment of diabetic gastroparesis.
