Aeterna Selects Treatment Candidate for Primary Hypoparathyroidism

Aeterna Zentaris, in collaboration with the University of Sheffield, in the U.K., selected AEZS-150 as its lead candidate for primary hypoparathyroidism and will begin formal preclinical studies to assess its therapeutic potential.

Data from this preclinical program may support the future launch of the first clinical trial to test the therapy in adults.

AEZS-150 was selected from a list of delayed clearance parathyroid hormone fusion polypeptides (DC-PTHs) developed by the University of Sheffield and licensed by Aeterna in March. Polypeptides are chains of amino acids, the building blocks of proteins.

The goal of DC-PTHs is to provide a molecule that mimics the effects of parathyroid hormone (PTH), which is missing in hypoparathyroidism, while remaining in the body for longer periods. This is expected to help patients maintain healthy blood levels of calcium and phosphate, which are regulated by PTH.

“We are very excited to have identified AEZS-150 as the development candidate within our DC-PTH program,” Klaus Paulini, PhD, Aeterna’s CEO, said in a press release.

“We look forward to continuing and advancing the development of our collaboration with the University and Prof. Dr. Ross,” Paulini said, adding that “we are now a step closer towards our common goal of potentially helping patients suffering from hypoparathyroidism.”

Richard J. Ross, MD, a professor of endocrinology at the university, has been involved in developing long-acting PTH molecules, and will work with Aeterna on its DC-PTH program.

“We are very optimistic about the development candidate AEZS-150 and the start of the preclinical program” that will further characterize the therapy, Ross said.

AEZS-150 is a fusion molecule comprising a modified growth hormone binding protein (GHBP) linked to the first 34 amino acids of PTH (PTH1-34) to mimic the natural hormone’s effects in the body.

Given that linking proteins to GHBP has been shown to delay clearance of the fusion molecule from the body, AEZS-150 is thought to enable PTH1-34 to persist in the body for one to two weeks.

In addition, AEZS-150 is being developed to be self-administered through an under-the-skin injection with a pharmaceutical pen.

“We are confident that Aeterna is the right partner to pursue the manufacturing process and the formal preclinical development,” Ross said.

Aeterna is in contact with contract manufacturing organizations to establish a good manufacturing practice process for the required toxicology and safety assessment of AEZS-150, Paulini said.