Interview with Dr. Marwan Sabbagh – why ALZ-101 represents a next-generation approach in Alzheimer’s Disease

Alzinova continues to strengthen its position ahead of the next development phase of its therapeutic vaccine candidate, ALZ-101. The engagement of Dr. Marwan Sabbagh, who has participated in more than 100 clinical trials in Alzheimer’s disease, represents a significant addition to the clinical program as preparations for Phase II progress. This is further supported by the recent scientific publication, which provides external validation of the Company’s clinical data and strengthens the foundation for ongoing development and partnering activities.

In this interview, Dr. Sabbagh shares his perspective on how Alzheimer’s treatments have evolved over time, the limitations of current approaches, and why emerging strategies such as active immunotherapy are gaining renewed attention.

The Alzheimer’s field has made significant progress in recent years, while also revealing clear limitations in the first wave of amyloid‑targeting therapies. How do you view the next phase of development, and where do you see the biggest unmet needs that are still not addressed?
“The passive immunotherapies are expensive and limited to effects while on the treatment. Having a more sustained and enduring effect is one gap not addressed in the current treatment paradigm. A drug like ALZ101 would also be more available to a larger population because passive immunotherapies have limited accessibility especially to rural patients. That is a second unmet need. The third unmet need is the potential to be used in a preclinical population.”

ALZ‑101 specifically targets neurotoxic amyloid‑beta oligomers rather than broader amyloid (plaque). From a clinical and mechanistic perspective, why is this oligomer‑specific approach interesting to you, and how might it translate into differences in patient outcomes?
“Through an iterative process, we now understand that not all species of amyloid are toxic. In fact, targeting species earlier in the cascade such as monomers and dimers has not been productive. The oligomeric species is known to be the toxic species. Therefore, targeting oligomeric species is logical.”

The Phase 1b study of ALZ‑101 showed a favorable safety profile, strong immunogenicity, and early signs that could indicate a disease‑modifying effect. When you look at the totality of the data, what do you find most compelling, and why?
“Active immunotherapies have had problems with immunogenicity and safety. Neither issue appeared in the Phase 1b study of ALZ101.”

Safety has been a major challenge for monoclonal antibodies targeting amyloid, particularly with ARIA. How do you weigh efficacy against safety and tolerability when you evaluate new therapies, and where do you see ALZ‑101 potentially fitting on that risk–benefit spectrum?
“There is the possibility of ARIA with all anti-amyloid agents. This will need to be assessed in larger phase 2 studies. The early studies of ALZ101 are encouraging. If no ARIA emerges, this will be as significant advancement.”

You have been involved in more than 100 clinical trials in Alzheimer’s disease over your career. What made you decide to engage operationally in Alzinova’s Phase 2 study with ALZ‑101, and what stood out compared with other programs you see?
“The return to active immunization. The journey with immunotherapies started with AN1792 then to passive immunotherapy. Moving back to active immunotherapy will be critical for sustainability. Very few companies have had success in advancing immunotherapy in this space.”

As you move into Phase 2 with ALZ‑101, what are the most important parameters and endpoints you believe must be demonstrated to show meaningful clinical value for patients and for regulators?
“First is safety, particilarly around ARIA. Second is sustained titers with the expectation that they will not wane over time. Third, being able to derive a clinical effect >28% seen with passive immunotherapies. Finally, consideration for prevention.”

Looking ahead, what would it take for ALZ‑101 to become part of the future treatment paradigm in Alzheimer’s disease - either alone or in combination with other therapies?
“The ultimate goal would be to give ALZ101 to all people at risk for developing AD in a prevention paradigm.”

For more information about the appointment of Dr. Marwan Sabbagh as Global Principal Investigator, see the press release published on February 16, 2026: https://www.alzinova.com/investors/press-releases/press/?slug=alzinova-engages-renowned-international-alzheimers-expert-as-global-principal-investigator-ahead-of-planned-phase-2-study

For more information, please contact:
Tord Labuda, CEO
E-mail: info@alzinova.com

About Alzinova AB
Alzinova AB is a Swedish biopharmaceutical company in clinical development specializing in the treatment of Alzheimer's disease, where the starting point is to attack toxic amyloid-beta oligomers. The lead candidate ALZ-101 is a therapeutic vaccine against Alzheimer's disease. Alzinova's patented AβCC peptide technology makes it possible to develop disease-modifying treatments that target the toxic amyloid-beta oligomers that are central to the onset and development of the 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 today. Based on the same technology, the company is also developing the antibody ALZ-201, which is currently in preclinical development, and the goal is to further expand the pipeline. The company's Certified Adviser on Nasdaq First North Growth Market is Mangold Fondkommission AB. For more information about Alzinova, please visit: www.alzinova.com