Alzinova AB says a second external safety review has been carried out of its clinical phase 1b study.
This resulted in a positive assessment to continue the study as planned. Behind the review is an independent expert group, Data and Safety Monitoring Board (DSMB), which continuously reviews the study.
Based on the patients included in the study, the DSMB recommended continuing the study as planned without adjustments.
The DSMB is an independent group of experts who review data during the study, with particular attention to safety. As specified in the study protocol, the DMSB meets periodically to examine the safety data accumulated during progress of the study, a standard procedure for all drug development.
Kristina Torfgård, CEO at Alzinova, said: “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 Alzheimer’s patients to live an independent and active life.”
The phase 1b clinical study with ALZ-101 in patients with early Alzheimer’s disease is a placebo-controlled, double blind, randomized 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 Alzinova’s 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. 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), which has experience in Alzheimer’s studies. The analysis of biomarkers will be made through a research collaboration with Sahlgrenska University Hospital in Gothenburg.
About Alzinova’s 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 said its 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.
Alzinova said it 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 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, 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.