Aeterna Zentaris outlines progress on development pipeline programs

Aeterna Zentaris provided an update on its therapeutic and diagnostic development pipeline programs and outlined upcoming key milestones. Therapeutics Development Pipeline Update: Autoimmunity Modifying Biologicals: Targeted, highly specific autoimmunity modifying fusion proteins for the potential treatment of neuromyelitis optica spectrum disorder and Parkinson’s disease: Recent Highlights: Demonstrated positive pre-clinical proof-of-concept in various in-vitro and in-vivo models. Next Steps: Evaluation of manufacturing strategy and initiation of production of selected development candidates. Ongoing compilation of a comprehensive pre-clinical data package for scientific advice meetings with regulatory authorities, expected to take place in the near future. Delayed Clearance Parathyroid Hormone Fusion Proteins: Potential treatment for chronic hypoparathyroidism. Recent Highlights: Detailed profiling of AEZS-150 through in-vitro studies and in-vivo models of hypoparathyroidism.. Next Steps: Meet with regulatory authorities to determine the development path forward; Company expects such a meeting in Q4/2023, and as outcome, an abbreviated safety and toxicology program as the active principle is already approved and in use. Initiate IND-enabling preclinical studies in 2024. Macimorelin Therapeutic: Ghrelin agonist in development for the treatment of ALS: Recent Highlights: Successful development of an alternative formulation suitable for use in ALS. Next Steps: Following achievement of proof-of-concept, the Company will seek to have a scientific advice meeting with regulatory authorities to discuss program development next steps. Completion of toxicology and safety studies to support treatment over prolonged periods. Diagnostics Development and Commercialization Update: Macimorelin Diagnostic: Approved and commercialized as test for adult growth hormone deficiency and in clinical Phase 3 development for childhood-onset growth hormone deficiency testing. Recent Highlights: Phase 3 Study: Significant progress made with DETECT patient recruitment also by engagement of an additional Clinical Research Organization. Currently three new countries, have ongoing DETECT clinical trial application activities and almost half the foreseen subjects have meanwhile concluded the trial. Macimorelin Commercialization: Having regained full rights to Macrilen for the U.S. and Canada from Novo Nordisk in May 2023, the Company is actively focused on identifying an alternate development and commercialization partner for Macrilen for U.S. and Canada