Alzinova AB (publ) announced that the company has received a positive response from the European Medicines Agency (EMA) regarding the planned clinical development program for the vaccine candidate ALZ-101. This constitutes an important validation of the quality of the project and represents significant progress in the preparation for the inclusion of European study centers in future clinical studies as well as in potential partnering discussions. During 2023, Alzinova has worked with regulatory interactions where advice from the EMA is an important part of the preparation for the next development phase.

Alzinova's request for scientific advice includes questions about the planned clinical development program, study design, preclinical development as well as chemistry, manufacturing and quality control. EMA has now provided a positive response to the dossier submitted by Alzinova. Alzinova has previously announced that the company has also received positive feedback from a pre-IND meeting with the US Food and Drug Administration (FDA).