Actionable news
0
All posts from Actionable news
Actionable news in AEZS: AEterna Zentaris Inc.,

Aeterna Zentaris Announces First Patient Enrolled for Confirmatory Phase 3 Trial of Macrilen™ for the evaluation of AGHD

QUEBEC CITY , Nov. 19, 2015 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS)(AEZ.TO) (the "Company") announced today that the first patient has been enrolled for the Company's confirmatory Phase 3 clinical study to demonstrate the efficacy of Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency ("AGHD").

David A. Dodd , Chairman, President and Chief Executive Officer of the Company, remarked, "We remain committed to the development of Macrilen™ because of our confidence in its efficacy and safety, as well as the medical need for such a convenient test in the absence of an FDA-approved diagnostic test for AGHD."

About the Study

The confirmatory Phase 3 clinical study of Macrilen™, entitled Confirmatory validation of oral macimorelin as a growth hormone (GH) stimulation test (ST) for the diagnosis of adult growth hormone deficiency (AGHD) in comparison with the insulin tolerance test (ITT), is designed as a two-way crossover study with the insulin tolerance test as the benchmark comparator and will involve some 30 sites in the United States and Europe . The study population will consist of approximately 110 subjects (at least 55 ITT-positive and 55 ITT-negative) with a medical history documenting risk factors for AGHD, and will include a spectrum of subjects from those with a low risk of having AGHD to those with a high risk of having the condition. The primary endpoint is validation of a single oral dose of macimorelin for the diagnosis of AGHD, using the ITT as a comparator. The coordinating investigator is Jose...


More