AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) announced that it has received written scientific advice from the European Medicines Agency (“EMA”) regarding the further development plan, including the study design, for the new confirmatory Phase 3 clinical study of Macrilen™ (macimorelin) for use in evaluating adult growth hormone deficiency (“AGHD”), following a Scientific Advice Meeting that was held earlier this month. As a result of the advice, the Company believes that the confirmatory Phase 3 study that was discussed with the U.S. Food & Drug Administration (“FDA”) last March, meets the EMA’s study-design expectations.
Dr. Richard Sachse, Chief Scientific Officer and Chief Medical Officer of the Company stated, “We are very pleased with the EMA’s advice as we continue to believe that our trial will confirm the efficacy and safety of this product. In principle, the EMA agreed with our proposed protocol design in the evaluation of the product. In addition, it proposed that we consider additional aspects regarding the demonstration of reproducibility of a diagnosis made using Macrilen™, which will further enhance the profile of our compound. We believe we will be able to provide the information that EMA requires in a timely and cost‑effective manner.”
David A. Dodd, Chairman and Chief Executive Officer of the Company commented on the future development of Macrilen™, “We are committed to moving forward swiftly with the development of Macrilen™ in AGHD. We believe that completion of the confirmatory Phase 3 study and the QT study will take 15 to18 months and will require a combined expenditure of between $5 million and $6 million. We have the resources necessary to bring this product to market and intend to do so as rapidly as possible, pending regulatory approvals.”
The multinational confirmatory efficacy Phase 3 clinical study with Macrilen™ for the evaluation of AGHD 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 of having the condition. The Company will submit a proposed final protocol to the FDA for their review prior to commencing the confirmatory efficacy Phase 3 study. A dedicated thorough Phase 3 QT study to evaluate the effect of Macrilen™ on myocardial repolarization is expected to be initiated in early 2016. (Original Source)
Shares of Aeterna Zentaris closed last Friday at $0.301. AEZS has a 1-year high of $1.54 and a 1-year low of $0.27. The stock’s 50-day moving average is $0.52 and its 200-day moving average is $0.57.
On the ratings front, Aeterna Zentaris has been the subject of a number of recent research reports. In a report issued on May 11, Canaccord Genuity analyst Neil Maruoka reiterated a Hold rating on AEZS, with a price target of $0.70, which implies an upside of 132.6% from current levels. Separately, on April 14, H.C. Wainwright’s Swayampakula Ramakanth upgraded the stock to Buy and has a price target of $1.25.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Neil Maruoka and Swayampakula Ramakanth have a total average return of 17.9% and 6.4% respectively. Maruoka has a success rate of 70.4% and is ranked #564 out of 3608 analysts, while Ramakanth has a success rate of 38.2% and is ranked #1332.
AEterna Zentaris Inc is a specialty biopharmaceutical company engaged in developing novel treatments in oncology, endocrinologyand women’s health.