Aeterna Zentaris Announces Continued Expansion of Intellectual Property Portfolio for Macimorelin with Additional Patent Applications
CHARLESTON, S.C., July 31, 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 announced the filing of two patent applications on July 22, 2020 related to its substance macimorelin, an orally available ghrelin agonist to be used in the diagnosis of patients with adult growth hormone deficiency (“AGHD”) and childhood-onset growth hormone deficiency
Based on the positive results from AEZS-130-P01 (“Study P01”) evaluating macimorelin as a growth hormone stimulation test for the evaluation of CGHD, the Company filed a U.S. provisional application as well as a patent application under PCT (Patent Cooperation Treaty). Both patent applications relate to the invention of macimorelin as a method to diagnose growth hormone deficiency in pediatric patients.
“We are encouraged with the data macimorelin has demonstrated to date and believe it holds significant potential to expand into pediatric use. These patent applications, once granted, are expected to support Aeterna’s business case for its continued development and efforts to seek regulatory approval pending the outcome of our second pediatric study, P02, evaluating macimorelin acetate in pediatric patients from 2 years of age to 18 years of age with suspected growth hormone deficiency,” commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna.
For results of Study P01, please visit EU Clinical Trials Register and reference EudraCT #2018-001988-23.
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.
In December 2017, the United States Food and Drug Administration (“FDA”) granted Aeterna Zentaris marketing approval for macimorelin to be used in the diagnosis of patients with adult growth hormone deficiency. Macrilen has been granted Orphan Drug designation by the FDA for diagnosis of AGHD. In January 2019, the European Commission granted marketing authorization for macimorelin to Aeterna Zentaris for diagnosis of growth hormone deficiency in adults. In March 2017, the Pediatric Committee of the EMA agreed to the Company’s PIP for macimorelin, a prerequisite for filing a marketing authorization application for any new medicinal product in Europe.