Aeterna Zentaris (AEZS) Announces the Selection of a Development Candidate in the DC-PTH Program for the Potential Treatment of Primary Hypoparathyroidism

May 6, 2021 8:17 AM EDT
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Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) through its wholly-owned subsidiary Aeterna Zentaris GmbH, (“Aeterna” or the “Company”), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced that, in consultation with The University of Sheffield, UK (the “University”), Aeterna has selected AEZS-150 as the lead candidate in the Company’s delayed clearance parathyroid hormone fusion polypeptides (DC-PTH) program. Aeterna will now start the formal preclinical development of AEZS-150 in preparation for a potential IND filing for conducting the first in-human clinical study of AEZS-150. AEZS-150 is being developed with the goal of providing a potential new treatment option of primary hypoparathyroidism in adults.

“We are very excited to have identified AEZS-150 as the development candidate within our DC-PTH program. We are in contact with CMOs to establish the GMP manufacturing process to prepare material for the required toxicology and safety assessment of AEZS-150. At this point in time the Aeterna team with its proven expertise can contribute on the formal development process of a new chemical entity (NCE). We look forward to continuing and advancing the development of our collaboration with the University and Prof. Dr. Ross. We are now a step closer towards our common goal of potentially helping patients suffering from hypoparathyroidism,” commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna.

AEZS-150 is a DC-PTH consisting of a modified growth hormone binding protein (GHBP) linked to PTH1-34. It is being developed with the goal of producing a product with delayed clearance of one or two weeks and the potential to be self-administered via a pharmaceutical pen. If successful, it would help patients maintain normal serum calcium and phosphate levels during chronic use. The technology is based on proprietary intellectual property exclusively licensed by Aeterna from the University.

Prof. Dr. Richard J. Ross of the University added, “We are very optimistic about the development candidate AEZS-150 and the start of the preclinical program. We will now focus on the further characterization of AEZS-150 in disease specific in-vitro and in-vivo models. We are confident that Aeterna is the right partner to pursue the manufacturing process and the formal preclinical development.”

Primary hypoparathyroidism, the first indication for candidate AEZS-150, is an orphan indication in the field of endocrinology. It is an uncommon condition in which the body produces abnormally low levels of PTH. PTH is a key regulating hormone essential for calcium homeostasis and renal phosphate clearance for maintaining a balance of those two minerals in the body. Untreated, primary hypoparathyroidism will cause, among other effects, renal dysfunction, muscle cramping, twitching, seizures, and cardiac arrhythmias. Approximately 23 to 37 in every 100,000 individuals in Europe and the U.S. are estimated to suffer from hypoparathyroidism.

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