Swiss-based pharmaceutical company Helsinn Therapeutics has recruited its first patient in a Phase III clinical programme evaluating Anamorelin HCl as a treatment of anorexia and cachexia in patients with advanced non-small cell lung cancer.
Anamorelin HCl is an orally administered ghrelin receptor agonist that has previously been studied in approximately 500 subjects.
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The two randomised, double-blind, placebo controlled, multicentre and global Phase III studies – Romana-1 and Romana-2 – are expected to enrol up to 477 patients each.
The primary efficacy endpoints include a measure of difference in the change in lean body mass and muscle strength in patients with weight loss associated with non-small cell lung cancer.
Pharmacokinetic and additional safety measures will also be evaluated in the trials.
Helsinn R&D senior vice-president John Friend said that earlier clinical studies have suggested that anamorelin may help to address the significant loss of weight and physical function experienced by many patients undergoing treatment for cancer.
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