Alzinova

“The communication with the FDA and EMA is important in the planning of the phase 2 study for our vaccine candidate ALZ-101. It is important to understand the authorities' requirements early on and to receive their guidance when planning and conducting our phase 2 study. We look forward to working with the FDA and EMA to develop ALZ-101 into a new effective and safe treatment for all those suffering from Alzheimer's disease.", comments Kristina Torfgård VD, Alzinova AB.

Alzinova announces today that the company has taken important steps in the development of its vaccine candidate, ALZ-101, for the treatment of Alzheimer's disease. The company has submitted a request for a Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA), while Alzinova has also applied for Scientific Advice from the European Medicines Agency (EMA).

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.