Aeterna Zentaris Provides Corporate Update
– Recently secured funding bolsters cash runway to fund operations and provides significant optionality for growth
– Pivotal Phase 3 safety and efficacy study AEZS-130-P02 (“Study P02”) expected to commence in Q1 2021
– Ongoing evaluations to expand pipeline seeking to transform into Company with multiple assets in development
– Efforts to secure a commercialization partner for macimorelin in Europe and other key global markets continuing
CHARLESTON, S.C., Sept. 16, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today provided a corporate update.
“Over the course of the last year since my appointment as CEO, a tremendous amount has been achieved. With the set intention to first assess and determine how best to support our current development partnership and how to maximize its success, followed by pursuing the expansion of macimorelin into pediatric use, I believe we are now well-positioned to advance Aeterna into its next phase of growth,” commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna. “A catalyst that has significantly powered the Company with the momentum we have today was successfully raising a total of $23.5 million since the beginning of this year. By strategically and opportunistically securing this capital, we believe we have both a solid foundation to support optionality moving forward and equipped the Company with necessary resources to enhance our pipeline in a meaningful way.”
“Our team is first and foremost focused on continuing our efforts to bring the expanded use of macimorelin over the finish line for the diagnosis of childhood-onset growth hormone deficiency (“CGHD”), an area of significant unmet need and, if approved, has the potential to significantly increase the available patient population for macimorelin. We are actively preparing, and hope to be able to commence, our pivotal Phase 3 safety and efficacy study AEZS-130-P02 (“Study P02”) in the first quarter of 2021,” added Dr. Paulini.
Macimorelin Clinical Program Update
The Company’s lead product, macimorelin, is the only United States Food and Drug Administration (“FDA”) approved oral drug indicated for the diagnosis of AGHD and is currently marketed in the United States (“U.S.”) under the tradename Macrilen, by Novo Nordisk. Aeterna is currently developing macimorelin for the diagnosis of CGHD, an area of significant unmet need, in collaboration with Novo Nordisk.