Alzinova announces new positive safety review of its Phase 1b study in Alzheimer's disease

Kristina Torfgård, CEO at Alzinova, comments:We are happy to have received continued positive feedback from the independent expert group and that the study shows that the treatment is well tolerated with no signs of that it is harmful. Alzinova has taken several important steps during the year in the development of the future treatment of Alzheimer's disease, a unique vaccine. One is that we have previously received a positive review by the DSMB as well as achieved success in recruiting to the study, where now more than half of the patients have been recruited. Furthermore, the vaccine is prepared to be produced in larger volumes for phase 2 development. All in all, it contributes to our key successes that also prepare the vaccine candidate for partnerships and increase interest in the market. We look forward to continuing to reach our milestones and in the future, bring this potential "best-in-class" treatment to the market. We are convinced that we will make it possible for…

GOTHENBURG, Sweden, 07/09/2022 (informazione.news - comunicati stampa - scienza e tecnologia)

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 .

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 a therapeutic 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, specific against toxic accumulations of amyloid-beta oligomers in the brain. These toxic substances are expected to be neutralized thus, protecting the brain's synapses from damage which could prevent the development of Alzheimer's disease. The treatment method is also expected to have a lower risk of side effects such as bleeding and edema. Therefore, the Company believes that it is likely to be more successful, unlike other broader approaches for treating Alzheimer's disease.

Kristina Torfgård, CEO
Tel. +46 708 46 79 75
E-mail:  kristina.torfgard@alzinova.com

 

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https://news.cision.com/alzinova/r/alzinova-announces-new-positive-safety-review-of-its-phase-1b-study-in-alzheimer-s-disease,c3626860

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