Alzinova AB (publ) (“Alzinova” or “the Company”), announces that a second external safety review has been carried out of the Company’s clinical phase 1b study – with 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 recommends continuing the study as planned without adjustments. The Company has previously communicated DSMB’s first review in April 2022, which also gave the green light to continue the study.
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The DSMB consists of an independent group of experts who review data during the study, with particular attention to safety. The details from the analysis are kept within the DSMB group and is not revealed to the Company, unless action is necessary regarding the execution of the study. 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, 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 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, 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.