QUEBEC CITY , Nov. 19, 2015 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 Manuel Garcia , MD, PhD, Associate Professor of Medicine-Endocrinology at Baylor College of Medicine in Houston , Texas.
Based on meetings with the US Food and Drug Administration ("FDA") as well as the European Medicines Agency ("EMA") and subsequent written scientific advice, the Company believes that the study meets the FDA's and the EMA's study-design expectations allowing US and European approval, if successful.
For more details on the trial, please consult this link: https://www.clinicaltrial.gov/ct2/show/NCT02558829?term=macimorelin&rank=1.
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. Macimorelin, under the trade name MacrilenTM, has been granted orphan drug designation by the FDA for diagnosis of AGHD. The Company owns the worldwide rights to this novel patented compound.
AGHD affects approximately 75,000 adults across the US, Canada and Europe . Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women's health. For more information, visit www.aezsinc.com.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995. Specifically, the statement that the Company believes that the confirmatory Phase 3 study of Macrilen™ meets the FDA's and the EMA's study-design expectations allowing US and European approval, if the study is successful, is a forward-looking statement. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects and clinical trials, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process, the potential inability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.
SOURCE Aeterna Zentaris Inc.