Alzinova announces positive safety review and continuation of its Phase 1b study… – Press Release


STOCKHOLM, April 28, 2022 /PRNewswire/ — Alzinova AB (publ) (FN STO: ALZ), a Swedish biopharma company developing treatments for Alzheimer’s disease by specifically targeting neurotoxic amyloid beta oligomers, today announces that the Data and Safety Monitoring Board (DSMB) completed a planned assessment of the ongoing ALZ-101 Phase 1b clinical study and recommended continuation of the study.

The DSMB consists of independent group of experts who review data during the study, with particular attention to safety. The data are kept within the DSMB group and may not be revealed to the company, unless action is necessary regarding the execution of the study. As specified in the ALZ-101 study protocol, the DMSB meets periodically to examine the safety data accumulated during progress of the study.

Kristina Torfgård, CEO at Alzinova, commented: “Even though we expected this favourable opinion from the DSMB, it is an important step in the development of ALZ-101. We are very proud to be advancing this potential “best in class” treatment for Alzheimer’s disease, and to bring hope to millions of patients and their loved ones who are suffering from this terrible 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. It is evaluating the vaccine candidate’s tolerability and safety. It is also studying the immunological response to the vaccine after multiple doses, as well as a number of biomarkers associated with Alzheimer’s disease. 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. 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,…