Alzinova has recruited half of the patients for the ongoing Phase 1b study of the vaccine candidate ALZ-101
Alzinova AB (publ) (”Alzinova” or “the Company”), announces today that the Phase 1b study for the unique vaccine candidate ALZ-101 against Alzheimer's disease is progressing according to plan and that the Company has now recruited half of the patients to the study where safety and tolerability is tested. The company expects the study to be fully recruited in 2022.
Alzinova's Phase 1b study for the vaccine candidate ALZ-101 against Alzheimer's disease continues according to plan and the study has now been recruited to 50%. Full recruitment is expected to be completed in 2022. The vaccine ALZ-101 is being evaluated in this Phase 1b study with a focus on investigating safety and tolerability in patients with Alzheimer's. In addition, the patient's immune response from the vaccine and other biological markers which may be indicative for the drug’s effect are being studied. In May, the company communicated a positive assessment from an independent expert group that critically reviewed the study's data, with particular attention to safety, which resulted in a recommendation to continue the study as planned.
Kristina Torfgård, CEO at Alzinova, comments:
“Our work continues according to plan, and we are carrying out several activities linked to the development of the vaccine ALZ-101. In part, we are still evaluating several potential clinics in Europe for this study, which will also be able to participate in the follow-up study as well as in the phase 2 study. With the help of great clinics and partners as well as with a clear strategy, we are well equipped to be able to complete a high-quality study where we aim to have recruited all patients in 2022. In parallel, we are conducting dialogues with various actors in the pharmaceutical industry in order to be able to enter into a partnership, continue the development of ALZ-101 and bring the product to market. The need for a well-working treatment is extensive and we are convinced that we will be able to deliver this.”
About ALZ-101
The market for treatment of Alzheimer's is large as there is currently no effective treatment to slow down the progress of or cure the disease. Alzinova's approach, to develop an active vaccine that specifically targets the toxic accumulations of amyloid-beta in the form of oligomers in the brain, has several advantages compared to other methods. Other players are developing treatments that target larger accumulations of amyloid-beta, so-called plaques in the brain, which are believed to contain both toxic and harmless protein. It has been shown that it is unlikely to be sufficiently effective and may result in serious side effects. Unlike these, Alzinova has succeeded in identifying a method that could specifically target the toxic accumulations in the brain (amyloid-beta oligomers) which is one of the causing factors behind Alzheimer's disease. Vaccination with ALZ-101 means that the body generates its own antibodies, specifically developed to eliminate the toxic accumulations of amyloid-beta oligomers in the brain. These toxic substances are expected to be neutralized and, in this way, nerve cells in the brain are protected from being damaged, which could prevent the development of Alzheimer's disease. The treatment method is also expected to have a lower risk of otherwise significant side effects such as bleeding and edema. Therefore, the Company believes that it will likely succeed, unlike other broader approaches for treating Alzheimer's disease.
More about the study
The Phase 1b clinical study with ALZ-101 in patients with early Alzheimer’s disease is a placebo-controlled, double blind, randomised First In Human (FIH) trial. In total, 26 patients will be included in the study. Study participants receive four doses of either ALZ-101 or placebo. The study is investigating two different dose strengths of ALZ-101 during a treatment period of 20 weeks. In October 2021, the first patient was recruited into the phase 1b clinical trial with the therapeutic vaccine ALZ-101. This was an important milestone and means that Alzinova is the first company with an oligomer-specific vaccine in the clinical phase. Enrolment in the study is ongoing and topline data for the study is anticipated in the second half of 2023.
The clinical trial is being carried out in Finland by Alzinova’s partner, Clinical Research Services Turku (CRST), who have extensive experience in Alzheimer’s studies. The analysis of biomarkers will be made through a research collaboration with Sahlgrenska University Hospital in Gothenburg.
For additional information, please contact:
Kristina Torfgård, CEO
Phone: +46 70 846 79 75
E-mail: kristina.torfgard@alzinova.com
Please note that this is an English translation of a press release written in Swedish by Alzinova AB, in the event of any inaccuracies, the Swedish version applies.
About Alzinova AB
Alzinova AB is a Swedish clinical-stage biopharma company developing treatments for Alzheimer’s disease by specifically targeting neurotoxic amyloid beta oligomers. The lead candidate, ALZ-101, is a therapeutic vaccine for the treatment of Alzheimer's. Alzinova’s proprietary AβCC peptide™ technology enables the development of disease-modifying therapies that has unique ability and precision to target the toxic amyloid-beta oligomers involved in the onset and progression of the disease. 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 is in preclinical development, 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