Alzinova AB interim report January - September 2020 - Seite 2
Alzinova has had an important and productive quarter - operations have developed successfully and proceed according to plan.
Our focus during the third quarter has been on the analysis of the technical batch of ALZ-101, alongside the continued work on the regulatory documentation that is required to initiate the clinical study with the therapeutic vaccine ALZ-101 in patients with Alzheimer's disease.
As previously disclosed, the analysis of the technical batch caused a delay in the supply of study drug. This analysis has now been completed. The results indicate that the drug substance is of high quality, and the final steps of the purification of vaccine for the study have thus been established. Work on production for the Phase 1b study has therefore been resumed according to plan. The study drug for the planned clinical study is projected to be supplied during the first quarter 2021.
The preparatory effort for the clinical study has further encompassed a so-called request for scientific advice, which the company has sought from the Finnish Medicines Agency, Fimea. The advice regarded clinical and regulatory aspects of the Phase 1b clinical trial. It is very gratifying that the authority shares the company's view that the pre-clinical package provides adequate support for an application to initiate the study in patients. The authority has further agreed with key aspects of the design and implementation of the study. This positive feedback allows us to make preparations to submit the application and initiate the clinical trial, with the aim of dosing the first patient during the second quarter of 2021.
ALZ-101 is a therapeutic oligomer-specific vaccine under development for the treatment of Alzheimer's disease. The vaccine is unique because its oligomer-specificity means that the body generates its own antibodies that target only the neurotoxic oligomers of amyloid-β, which are believed to be the cause of Alzheimer's disease.
Data from clinical studies conducted with other drug candidates, both those that bind non-specifically and others that bind to differing degrees to various forms of amyloid-β, show that oligomer-specificity is important to achieve efficacy as well as to avoid adverse side effects.
We are now looking forward to initiating the clinical study of the therapeutic vaccine ALZ-101 which, through its unique oligomer-specificity, provides opportunities for developing both an effective and well tolerated product to treat Alzheimer's disease and thus substantially improve the lives of Alzheimer's patients.