Friday turned out to be a nightmare for shareholders of AEterna Zentaris Inc. (USA) (NASDAQ:AEZS), after the drug maker announced that its ZoptEC Phase 3 clinical study of Zoptrex™ (zoptarelin doxorubicin) in women with locally advanced, recurrent or metastatic endometrial cancer did not achieve its primary endpoint of demonstrating a statistically significant increase in the median period of overall survival of patients treated with Zoptrex™ as compared to patients treated with doxorubicin.
The news sent AEterna Zentaris’ share price collapsing, down nearly 60% to $1.35 in pre-market trading Friday.
Chief Scientific Officer Richard Sachse commented, “The median overall survival period for patients treated with Zoptrex™ was 10.9 months compared to 10.8 months for patients treated with doxorubicin. This is not a statistically significant, clinically meaningful increase in overall survival and thus the ZoptEC Phase 3 clinical study did not meet its primary endpoint. In addition, Zoptrex™ generally performed no better than the comparator drug with respect to the secondary efficacy endpoints. For example, the median period of progression-free survival of the patients in the Zoptrex™ arm of the study was identical to that for patients in the doxorubicin arm. Finally, there was no meaningful difference between the two arms with respect to safety; the number of patients with cardiac disorders was similar – eight in the Zoptrex™ arm and nine in the doxorubicin arm. Therefore, the results of the study are not supportive to pursue regulatory approval.”
Chief Executive Officer David added, “We are very disappointed with the outcome of the ZoptEC Phase 3 clinical study. Based on this outcome, we do not anticipate conducting clinical trials of Zoptrex™ with respect to any other indications. I would like to thank my colleagues within Aeterna Zentaris and our external team of clinical investigators for their dedication to and contributions on this project.” Commenting on the Company’s plans, Mr. Dodd continued, “Our focus has now shifted entirely to filing our new drug application for Macrilen™ and, if the product is approved, to its commercial launch as soon as possible. We will also optimize our resources to be consistent with our focus on Macrilen™-related efforts. We continue to believe in the potential that Macrilen™ provides for us to become a focused specialty pharmaceutical company. Our intention is to submit the Macrilen™ NDA in the third quarter of 2017 and, if the product receives FDA approval, to commercially launch the product in the first quarter of 2018.
Æterna Zentaris, Inc. operates as a specialty biopharmaceutical company that is engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. The company’s pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. It focuses on the development of Perifosine, Cetrotide, Ozarelix, AEZS-108 and AEZS-130.