Alzinova AB (“Alzinova” or the “Company”) today announces that an application for ethical review and approval of its planned Phase 2a ADVANCE study has been submitted to Advarra, a US Institutional Review Board (IRB). The submission covers the seven selected US clinical trial sites and represents a further step in the preparations for evaluating the vaccine candidate ALZ-101 in participants with early Alzheimer’s disease.
Tord Labuda, CEO of Alzinova, comments:
“We are focused on execution. With seven US clinical trial sites selected, our IND documentation updated and the ethics application now submitted, we are systematically advancing the preparations required to initiate ADVANCE. Our priority is clear, to move ALZ-101 into the next phase of clinical development and generate the evidence needed to assess its therapeutic potential in a larger patient population. Our focus is now on completing the remaining preparations and moving ADVANCE toward the planned initiation of patient enrolment.”
The ethics submission forms part of Alzinova’s ongoing regulatory and operational preparations for ADVANCE, a global Phase 2a study planned to include approximately 120 participants with early Alzheimer’s disease. The study is planned to be conducted in the United States, the European Union and the United Kingdom.
An Institutional Review Board (IRB) is an independent ethics committee responsible for reviewing clinical studies to protect the rights, safety and welfare of participants. The review includes an assessment of the study design, the balance of potential risks and anticipated benefits, as well as the participant information and informed consent process. Ethical approval is required before the relevant clinical trial activities involving participants can begin at the US sites.
The submission follows Alzinova’s recent update to its existing FDA-cleared Investigational New Drug (IND) and forms part of the continued preparations for initiating ADVANCE. Enrolment of the first participant is currently targeted around the turn of 2026/2027.
For further information, please contact:
Tord Labuda, CEO
E-mail: IR@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