AETERNA ZENTARIS ANNOUNCES EMA DECISION TO ACCEPT A MODIFICATION TO AN AGREED PEDIATRIC INVESTIGATION PLAN FOR MACIMORELIN

– Modifications recommended for some key elements of planned safety and efficacy Study P02 –

– Modifications to the outline of Study P02 requested to ensure a harmonized global study protocol complying with requirements from EMA as well as FDA –

CHARLESTON, S.C., April 07, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna Zentaris” or the “Company”), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced the decision of the European Medicines Agency (“EMA”) to accept a modification request by Aeterna Zentaris of the Company’s Pediatric Investigation Plan (“PIP”) for macimorelin as originally approved in March 2017 which covered the conduct of two pediatric studies and defined relevant key elements in the outline of these studies.

The Company recently announced the positive results and successful completion of the first of these studies, Study P01. The goal of Study P01 was to establish a dose that could both be safely administered to pediatric patients and cause a clear rise in growth hormone concentration in subjects ultimately diagnosed as not having GHD.

The second pediatric study, Study P02, is designed to investigate the diagnostic efficacy and safety of macimorelin acetate in pediatric patients from 2 years of age to 18 years of age with suspected growth hormone deficiency.

“This EMA decision is an important milestone for us, as it supports the development of one globally harmonized study protocol for test validation - Study P02 - which will be accepted both in Europe and the United States of America,” said Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris.

“A request for modification of the PIP related to some of the key elements of Study P02 became necessary for Aeterna Zentaris, as we wanted to ensure that the study protocol will comply with expectations and requirements from both EMA as well as United States Food and Drug Administration.  This represents a very exciting advancement for our pediatric development program,” commented, Dr. Nicola Ammer, Chief Medical Officer of Aeterna Zentaris.

About macimorelin

Macimorelin, a ghrelin agonist, is an orally-active small molecule that stimulates the secretion of growth hormone from the pituitary gland. Stimulated growth hormone levels are measured in blood samples after oral administration of macimorelin for the assessment of GHD.