BOSTON, April 4, 2016 /PRNewswire/ -- Motus announced today the presentation of clinical proof-of-concept data for relamorelin (RM-131), Motus' ghrelin agonist, in anorexia nervosa. Analysis of the data indicates that relamorelin administered once daily for four weeks significantly improved gastric emptying time and led to a trend in weight gain in patients with anorexia nervosa. The results were presented at the ENDO2016 conference held April 1-4, 2016, in Boston.
The Phase 2 proof-of-concept study was a randomized, double-blind, placebo-controlled trial in 22 female patients with anorexia nervosa treated with either placebo or relamorelin 100 mcg once daily for a period of four weeks. The primary objective of the study was to evaluate the effect of relamorelin on gastric emptying time and weight. The trial also assessed safety and tolerability.
In the poster, "Short-Term Treatment with a Ghrelin Agonist Significantly Improves Gastric Emptying in Anorexia Nervosa," Pouneh Fazeli, MD, Neuroendocrine Unit at Massachusetts General Hospital, presented the following clinical data:
- Gastric emptying time was significantly shorter compared to placebo (p=.03).
- Weight gain was greater compared to placebo, with a trend toward significance (p=0.12): The relamorelin group gained 0.86 + 0.4 kg compared to 0.04 + 0.28 kg in the placebo group.
- The drug was generally well tolerated, although two subjects receiving relamorelin did not finish the study due to feelings of increased hunger.
"The results of this initial clinical trial of relamorelin in anorexia are very promising," said Anne Klibanski, MD, Chief of the Neuroendocrine Unit at Massachusetts General Hospital, and the senior investigator for the study. "These results suggest that relamorelin may have the potential to treat anorexia in two ways: by stimulating hunger directly, and also by normalizing gastric emptying in patients with anorexia. We recommend further clinical studies of relamorelin to determine long-term efficacy and safety for the treatment of anorexia nervosa."
Anorexia nervosa (AN), a psychiatric disease predominantly affecting women, is characterized by chronic starvation, low body weight, and fear of weight gain. Despite low caloric intake, many women with AN report less of a desire to eat compared to normal-weight women. Delayed gastric emptying—reported in as many as two-thirds of patients with AN—may be a mediator of this decrease in hunger. AN has one of the highest mortality rates among psychiatric illnesses, with a critical need for new treatments. Ghrelin is an orexigenic hormone that promotes gastric motility and emptying. Ghrelin levels are elevated in AN, suggesting that AN is a state of ghrelin resistance.
About Relamorelin (RM-131)
Relamorelin is a ghrelin agonist in development for the treatment of diabetic gastroparesis and gastrointestinal (GI) functional disorders. Derived from the natural ghrelin sequence, relamorelin has been optimized to stimulate GI motility, with greater potency and enhanced stability and pharmacokinetics. Relamorelin has completed a Phase 2a clinical trial in diabetic gastroparesis and a Phase 2a study in chronic constipation. The U.S. Food and Drug Administration (FDA) has granted Fast Track review status to relamorelin for the treatment of diabetic gastroparesis.
Motus is a biopharmaceutical company focused on developing peptide therapeutics for the treatment of gastrointestinal (GI) diseases. Motus, formerly Rhythm Health, Inc., is a subsidiary of Rhythm Holding Company, LLC and is based in Boston, Massachusetts.
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