AEterna Zentaris Inc. (NASDAQ:AEZS) obtained positive results for the dosing of Macimorelin in AEZS-130-P01 to detect the cause of growth hormone deficiency in children. The company will begin the efficacy and safety study AEZS-130-P02 in Q1 2021.
In discussions with partners for commercialization
AEterna is negotiating with partners worldwide for commercializing Macimorelin in several global markets, including Europe. It expects to tap unmet needs for diagnosing growth hormone deficiency (GHD) and boost revenues. The company intends to expand this program for diagnosing GHD in adults.
CEO of AEterna, Dr. Klaus Paulini, said the company is excited to achieve significant clinical trials in Q2 2020 without any delay despite the ongoing coronavirus crises. It is giving utmost priority to the safety of its employees while ensuring continued operations.
Klaus said the company advanced the development of Macimorelin for GHD in children. If approved, it will provide a significant revenue-generating opportunity for the company going forward. The company received approval from EMA for modified PIP (Pediatric Investigation Plan), allowing it to commence P02 study and comply with the FDA and EMA requirements.
Raises a capital of $19 million
AEterna raised funds of $19 million, $7 million through the registered direct offering, and $12 million through a public offering.
AEterna will present an abstract of the study results for its lead GHD lead candidate Macimorelin at e-ECE 2020 (22nd European Congress of Endocrinology) from September 5 to 9, 2020.
Inks a commercialization pact with Megapharm
AEterna signed an agreement with Israel-based biopharmaceutical company, Megapharm Ltd, for the exclusive distribution of its Macimorelin in Palestine and Israel.
AEterna already received approval from the US FDA for oral administration of Macimorelin to diagnose AGHD. Macimorelin is sold under the trademark – Macrilen in the US. It collaborates with Novo Nordisk in the development of Macimorelin for CGHD.
Applies for two patents
AEterna applied for a patent for ghrelin agonist, which is used in orally administrable Macimorelin. It also applied for a patent for CGHD. Both the patents are related to macimorelin intervention to diagnose GHD in pediatric patients.
Klaus said the company is pleased with the data obtained from the use of Macimorelin and its potential for pediatric use.
AEterna posted a net loss of $3.5 million in Q2 2020. It is on the backdrop of change in the fair value of warrants.