Alzinova AB (publ) announced that the company has successfully concluded a pre-IND meeting with the US Food and Drug Administration (FDA) receiving positive feedback on the planned clinical development program for the vaccine candidate ALZ-101. This marks an important validation of the project's quality and represents a step for potential partnering discussions, as well as for the pathway towards the submission of an application to include US study centers in future clinical studies (Investigational New Drug Application, IND). During the spring, Alzinova formally requested a meeting with the FDA and in June the company announced that the FDA had accepted Alzinova's pre-IND meeting request.

The primary objective of the meeting was to discuss the overall clinical development plan for ALZ-101. Based on the background material and questions provided by Alzinova, the FDA answered questions about the study design, the clinical development program and preclinical development, as well as chemistry, manufacturing and quality control.