Aeterna Zentaris provides business update, upcoming milestones

Aeterna Zentaris provided a business update and outlined upcoming key milestones. "We have made significant development progress since we initiated six pre-clinical development programs in 2021," said Dr. Klaus Paulini, Chief Executive Officer of Aeterna. "We have established a growing body of data towards our pre-defined go/no-go decision points with the goal of enabling us to identify and select from those programs the most compelling opportunities that warrant continued development. We believe that we have built the foundation for continued momentum and are very encouraged with the disciplined progress we have made thus far." 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: Aeterna is currently conducting its pivotal Phase 3 safety and efficacy study AEZS-130-P02 evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency. Most clinical sites in the U.S. as well as European countries are open for patient recruitment. Recent Highlights: Phase 3 Study: Bolstered enrollment expected by the replacement of inactive countries/sites and engagement of an additional Clinical Research Organization. Currently four new countries, have ongoing DETECT clinical trial application activities. Macimorelin Commercialization: Having announced that Aeterna Zentaris will regain full rights to Macrilen for the U.S. and Canada from Novo Nordisk in May 2023, the Company is progressing its efforts to seek an alternate development and commercialization partner for Macrilen in those countries for continued commercialization of Macrilen in adult growth hormone deficiency and development and commercialization of Macrilen in CGHD. Achieved regulatory approval for Macrilen as AGHD diagnostic product in Israel. Next Steps and Expectations: Achieve approvals to conduct the DETECT trial in the new countries in the first half of 2023. Complete DETECT enrollment by the end of 2023. Continue efforts to secure a U.S. and Canadian development and commercialization partner for Macrilen in AGHD and CGHD. Achieve regulatory approval for Macrilen as AGHD-diagnostic in South Korea, Turkey and some non-EU Balkan countries