+ Regulatory
Press release submission | Oct 2, 2021

Alzinova receives approval to start the first clinical study with the oligomer-specific ALZ-101 vaccine in patients with Alzheimer's disease

Alzinova issued the following announcement on Sep. 30. 

Alzinova AB (publ) (FN STO: ALZ), a Swedish biopharma company specialising in the treatment of Alzheimer's disease by specifically targeting neurotoxic amyloid-beta oligomers, announced today that the company has received approval from the regulatory authorities in Finland to initiate the first clinical study with the vaccine candidate, ALZ-101.

The Phase 1b clinical study with ALZ-101 in Alzheimer's patients will evaluate the vaccine candidate's tolerability and safety. It will also study the immunological response to the vaccine after multiple doses, as well as a number of biomarkers that are associated with Alzheimer's disease.

The study will be carried out in collaboration with Alzinova's partner, Clinical Research Services Turku (CRST), in Finland who have extensive experience in Alzheimer's studies and the biomarker work will be done in the context of a research collaboration together with Sahlgrenska University Hospital in Gothenburg. Ethical approval is already in place, and the first patient in the study will be recruited shortly.

Amyloid-beta is considered to be a key factor in the development of Alzheimer's disease, and in particular, the soluble oligomeric forms of amyloid-beta appear to be harmful. These are specifically targeted by the ALZ-101 vaccine.

"Taking our therapeutic vaccine, ALZ-101, into the clinical phase and continuing our important work to treat and prevent the progression of Alzheimer's disease is a very important and inspiring milestone. Alzheimer's disease is an area in great need of new and more effective treatments. Our goal to develop a long-acting and effective treatment that enables patients to live an active and independent life, free from the effects of Alzheimer's disease, has now come a bit closer," says Kristina Torfgård, CEO of Alzinova.

For more information, please contact:
Kristina Torfgård, CEO
tel: +46 708 46 79 75
E-mail: kristina.torfgard@alzinova.com

This information is information that Alzinova AB is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication, through the agency of the contact person set out above, at  2:06 p.m. CEST on September 30, 2021.

About Alzinova AB

Alzinova AB is a Swedish biopharma company specializing in the treatment of Alzheimer's disease targeting neurotoxic amyloid-β oligomers. The lead candidate, ALZ-101, is being developed as a therapeutic vaccine for the treatment of Alzheimer's. Alzinova's proprietary AβCC peptide™ technology enables the development of disease-modifying therapies that target the toxic amyloid-β oligomers involved in the onset and progression of the disease with high precision. Alzheimer's is one of the most common and devastating neurological diseases globally, with of the order of 40 million people afflicted today. In addition, the antibody ALZ-201, in early preclinical development, was generated with the AβCC peptide™ technology and the ambition is to expand the pipeline further. The company's Certified Advisor on Nasdaq First North Growth Market is Corpura info@corpura.se +46 768-532 822. For more information about Alzinova, please visit: www.alzinova.com 

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