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  • Aeterna Zentaris (AEZS) begins preclinical development of Macimorelin as a potential new treatment option for patients with Amyotrophic Lateral Sclerosis (ALS, Lou Gehrig’s Disease)
  • Researchers at The University of Queensland will conduct preclinical studies in disease-related in-vitro and in-vivo models of ALS to demonstrate the therapeutic potential of Macimorelin
  • Aeterna Zentaris’ lead product, Macimorelin, is the only USFDA-approved oral drug indicated for the diagnosis of adult growth hormone deficiency 
  • Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products
  • Aeterna Zentaris Inc. (AEZS) is up 1.02 per cent and is trading at C$0.88 at 1:14 pm ET

Aeterna Zentaris Inc. (AEZS) has launched a preclinical program to qualify Macimorelin as a potential treatment option for ALS (Lou Gehrig’s disease).

The preclinical development program is part of the recently executed Material Transfer Agreement (MTA) with The University of Queensland.

A team of university researchers, led by Frederik Steyn, MSc, Ph.D., will conduct preclinical studies in disease-related in-vitro and in-vivo models of ALS to demonstrate the therapeutic potential of Macimorelin on disease progression and ALS-specific pathology.

The researchers recently filed funding applications to dedicated organizations in Australia to finance parts of the abbreviated preclinical development program and to conduct a subsequent investigator-initiated clinical trial to evaluate the safety, tolerability and efficacy of Macimorelin as a potential new treatment option for ALS patients.

Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris, commented,

“The start of the preclinical phase represents a significant milestone in the development of a potential new treatment option for ALS to help patients with this terrible, incurable disease and to improve their quality of life.”

“We look forward to supporting Dr. Steyn’s research team in addressing this significant unmet medical need,” added Paulini.

In the event of positive preclinical results, Aeterna has the exclusive right to acquire a license from The University on the therapeutic use of Macimorelin for the treatment of ALS.

Aeterna Zentaris’ lead product, Macimorelin, is the only United States Food and Drug Administration (USFDA)-approved oral drug indicated for the diagnosis of adult growth hormone deficiency and is currently marketed in the United States under the tradename Macrilen™, by Novo Nordisk.

It is also licensed to Consilient Health Ltd. for the European Economic Area and United Kingdom, and Megapharm Ltd. for Israel and the Palestinian Authority.

Aeterna Zentaris is currently developing Macimorelin for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need, in collaboration with Novo Nordisk.

Ghrelin is a natural hormone stimulating the release of growth hormone. Its level is often reduced in ALS patients and stimulation of GH excretion improves survival in ALS mouse models.

Ghrelin and ghrelin mimetics have already demonstrated in preclinical models stimulation of growth factors to protect motor neurons and enhance muscle building, stimulate appetite, slow metabolism to promote positive energy balance and dampen neuroinflammatory processes.

Dr. Steyn’s research team at The University have confirmed these positive effects of ghrelin mimetics in several experiments.

Ghrelin itself is not qualified as medicine because of rapid clearance from circulation. However, Macimorelin is an orally active ghrelin agonist and could mimic the biological effect of the hormone via mechanisms similar to ghrelin.

Amyotrophic lateral sclerosis (ALS) is the most common motor neuron disease (MND).

Most patients with ALS present with random, asymmetric symptoms, consisting of cramps, weakness, and muscle atrophy of the hands or feet. Weakness progresses to the forearms, shoulders, and lower limbs.

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 growth hormone deficiency (GHD).

Macimorelin is currently marketed in the United States under the tradename Macrilen™, through a license agreement with Novo Nordisk.

Macimorelin is the only U.S. FDA and European Commission-approved oral test indicated for the diagnosis of AGHD.

Through a license agreement with Consilient Health Ltd, Macimorelin will be commercialized in Europe and the United Kingdom upon receipt of pricing and reimbursement approvals in the particular country. 

Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need.

Aeterna Zentaris Inc. (AEZS) is up 1.02 per cent and is trading at C$0.88 at 1:14 pm ET.

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