Alzinova AB (publ) announced that a request for a Pre-IND meeting with the US Food and Drug Administration (FDA) has been submitted and an application for EMA Scientific Advice from the European Medicines Agency (EMA). The purpose of these regulatory interactions is to prepare for the company's Phase 2 study with the ALZ-101 vaccine candidate being developed for the treatment of Alzheimer's disease. These regulatory applications aim to obtain advice and guidance from the authorities regarding the development plan for ALZ-101 and to ensure that it meets the regulatory requirements in both the US and the EU.

By interacting early with the authorities, Alzinova can prepare for the upcoming applications and thereby shorten the time it takes to start the next clinical study - the phase 2 study. This strategy helps the company to more quickly reach important milestones in the development process to offer a new treatment for patients suffering from Alzheimer's disease. These are important steps for the commercial development as well as future partnerships for ALZ-101.