Alzinova

Alzinova AB (publ) (FN STO: ALZ), announces today 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.

“The response from EMA is of great help in the continued clinical development of ALZ-101 where the positive feedback from EMA is a clear confirmation that the documentation is of high quality. Through early interactions with the regulatory authorities, we can increase the possibility of a successful development process for the vaccine candidate ALZ-101. We are now looking towards the next milestone - topline data in the fourth quarter of this year.", comments Kristina Torfgård CEO, Alzinova AB.

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).

More about the interactions with FDA and EMA
The regulatory interactions 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 both in the US and in the EU. By interacting early with the authorities, Alzinova can prepare for the upcoming applications for 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 also important steps for the commercial development and future partnerships for ALZ-101.