Therapy Areas: Vaccines
Alzinova receives positive safety review of Phase 1b study in Alzheimer's disease
28 April 2022 -

Alzinova AB (publ) (FN STO:ALZ), a Swedish biopharmaceutical company developing treatments for Alzheimer's disease by specifically targeting neurotoxic amyloid beta oligomers, announced on Thursday that the Data and Safety Monitoring Board (DSMB) has completed a planned assessment of the ongoing ALZ-101 Phase 1b clinical study and recommended continuation of the study.

The DSMB consists of an 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 DSMB meets periodically to examine the safety data accumulated during progress of 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 that 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.

The clinical trial is being carried out in Finland by Alzinova's partner, Clinical Research Services Turku (CRST).

The analysis of biomarkers will be made through a research collaboration with Sahlgrenska University Hospital in Gothenburg, the company added.