Alzinova takes the next step towards a phase II study in the US

ALZ-101 is a therapeutic vaccine based on Alzinova’s patented AβCC peptide technology. The technology makes it possible to develop disease-modifying treatments that attack the toxic amyloid-beta oligomers that are central to the onset and development of Alzheimer’s disease with great accuracy.

From a global perspective, Alzheimer’s disease is one of the most common and devastating neurological diseases, with around 40 million affected globally.

Based on the same AβCC peptide technology, Alzinova is also developing the antibody ALZ-201,  which is in the preclinical development phase.

Faster development with FDA filings

Alzinova has now submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA), which is a requirement for starting clinical studies in the US. The application includes, among other things, study design and quality and safety data for ALZ-101.

In parallel, the company has also applied for Fast Track designation, a regulatory program that aims to accelerate the development and review of drugs that address serious diseases with significant unmet medical needs.

Fast Track designation would bring several benefits to Alzinova, including more frequent meetings with the FDA, the possibility of an accelerated approval process and priority review of applications. Receiving Fast Track designation could significantly shorten the time to market for ALZ-101.

Phase II study planned to start in the second half of 2025

The planned Phase II study with ALZ-101 is expected to commence in the second half of 2025, subject to FDA approval of the company’s IND application. The study will evaluate the safety, tolerability, and efficacy of ALZ-101 in patients with early Alzheimer’s disease.

Comments from the CEO

Alzinova’s dual filings with the FDA signal an ambitious strategy to rapidly advance ALZ-101 toward the market. We contacted CEO Tord Labuda for a comment.

How do you see the IND application affecting Alzinova’s timeline and preparations for the Phase II study in the US?

– The IND application to the FDA is a milestone that enables us to now advance towards clinical studies in a structured way. The process involves carefully documenting the study design, safety and quality data for ALZ-101 according to US regulatory requirements. Approval of the application is crucial to be able to start our planned phase II study in the second half of 2025. Preparations for the study are now being intensified, including organizational and logistical steps such as selecting study centers, training investigators, and preparing recruitment strategies.

What would a Fast Track status mean in concrete terms for the ALZ-101’s ability to reach the market faster?

– A Fast Track designation from the FDA provides several concrete benefits: more frequent and regular dialogues with the FDA, the opportunity for accelerated review of both study protocols and future marketing applications, and the potential for so-called ”rolling review” when certain parts of the application are evaluated on an ongoing basis. It can shorten development time, reduce regulatory bottlenecks, and accelerate the time to market for patients with early Alzheimer’s disease.

What steps are you and your team taking to ensure the smoothest possible FDA review of ALZ-101?

– We have carefully prepared the documentation for the IND application in accordance with the FDA’s requirements and guidelines. Our team has also engaged external regulatory advisors and held pre-IND meetings with the FDA to ensure that study design and data meet expectations. We will continuously communicate with the agency, quickly address questions and be proactive in handling any additional requirements or requests, all to ensure an effective review and shorten the time to study start.

Finally, how do you see the possibility of securing funding through a license agreement with a partner, and what impact would it have on keeping to the timeline for the phase II study?

– We see partnerships as an attractive way to quickly secure the resources required to drive the project forward, which in the short term can create significant value. At the same time, it is important to weigh this against the alternative of conducting a company-funded study. Although it involves greater initial investment and a higher commitment, it allows us to retain a larger share of the future commercial rights. In the long run, this can create greater long-term value for our shareholders. Our strategy is to carefully evaluate both options to both meet patient needs and optimize value creation over time.