Aeterna Zentaris adds a Phase III trial to CRO Ergomed’s plate

29-Jun-2015 - Last updated on 29-Jun-2015 at 21:22 GMT

Aeterna Zentaris has selected UK-based Ergomed again for a clinical trial, this time for a confirmatory Phase III study to demonstrate the efficacy of Macrilen (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency (AGHD).

The trial will be conducted as a two-way crossover study with the insulin tolerance test as the benchmark comparator. The study population will consist of patients with a medical history documenting risk factors for AGHD and will include a spectrum of patients from those with a low risk of having AGHD to those with a high risk.

The companies previously partnered in a risk-sharing deal for a Phase III trial of a potential endometrial cancer treatment.

David Dodd, Chairman, President and CEO of Aeterna Zentaris offered high praise for Ergomed from that relationship, noting that its “performance as our clinical research organization supporting our pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer has been excellent.”

Ergomed also recently worked with Ferrer to develop a new insomnia drug.