Aeterna Zentaris has recruited the first patient in a Phase IIa trial of AEZS-130, a ghrelin agonist, in cancer cachexia patients.
AEZS-130 is a novel orally-active small molecule that stimulates the secretion of growth hormones by binding to the ghrelin receptor (GHSR-1a).
The double-blind, randomised study, being conducted under a cooperative research and development agreement between Aeterna Zentaris and the Michael E DeBakey Veterans Affairs Medical Center, is designed to test the effects of different doses of AEZS-130 in 18 to 26 patients with cancer-cachexia.
Aeterna Zentaris president and CEO Juergen Engel said; "Because cachexia is very common among cancer patients, our oral ghrelin agonist, AEZS-130, could represent a novel treatment option for many of the 1.5m people diagnosed with cancer each year, in the US alone."
Following the safety and efficacy analysis at each dose level versus a placebo, which involves three sequential groups receiving differing doses of AEZS-130, the decision to either decrease or increase the dose will be taken.
Adequate efficacy is defined in the study as a =0.8kg of body weight gain or a =50ng/mL increase in plasma IGF-1 levels.
The safety and efficacy of repeated oral administration of AEZS-130 at different doses daily for one week, in view of developing a treatment for cachexia, is the primary objective of the placebo-controlled study.
Other secondary objectives include food intake and changes in appetite, muscle strength, energy expenditure, reward from food and functional brain connectivity.