Alzinova AB (publ) has received positive feedback from the Finnish Medicines Agency Fimea in view of the upcoming clinical trial application for the ALZ-101 Alzheimer's disease vaccineDate: 2020-10-15
Alzinova has received positive feedback in scientific advice from the Finnish Medicines Agency Fimea. The advice regarded clinical and regulatory aspects of the Phase 1b clinical trial with the therapeutic vaccine ALZ-101 that the Company plans to initiate in Alzheimer's disease patients in Finland during the second quarter of 2021.
Through the scientific advice, Alzinova has confirmed with Fimea that the pre-clinical package on which the planned clinical trial will be based supports the initiation of the study. Certain key design features for the clinical trial were also agreed with the authority. The preparations to submit the application and start the study continue according to plan. The aim is to initiate the study and dose the first patient during the second quarter of 2021.
”We are very pleased with the positive dialogue with Fimea. The fact that we have now received support for the crucial parameters for the design and implementation of the Phase 1b study represents a major step towards starting it – and thus also towards commercialisation.This feedback allows us to confidently focus on the final stages of planning before submitting our clinical trial application," says Kristina Torfgård, CEO of Alzinova.
Alzinova develops the ALZ-101 vaccine candidate to treat Alzheimer's disease. The disease is characterized by aggregation of the Amyloid-β peptide in brain tissue, and the Company's immunotherapy specifically targets the oligomeric, neurotoxic forms of the peptide aggregate that are considered to be the cause of the disease.
The Company intends to conduct a clinical First-in-Human Phase 1b study inpatients suffering from early-onset Alzheimer's disease.
For more information, please contact:
Kristina Torfgård, CEO
Telephone: +46 708 46 79 75
The information was submitted for publication, through the agency of the contact person set out above, at 08:01 a.m. CEST on October 15, 2020.
Alzinova AB is a Swedish biopharma company specializing in the treatment of Alzheimer’s disease by targeting neurotoxic amyloid-β oligomers. The lead candidate, ALZ-101, is in late preclinical development as a therapeutic vaccine for the treatment of Alzheimer's. Alzinova’s proprietary AβCC peptide™ technology enables the development of disease-modifying therapies that target the toxic amyloid-β oligomers involved in the onset and progression of the disease with high precision. Alzheimer’s is one of the most common and devastating neurological diseases globally, with of the order of 40 million people afflicted today. In addition, the antibody ALZ-201, in early preclinical development, was generated with the AβCC peptide™ technology and the ambition is to expand the pipeline further. The Company’s Certified Advisor on Nasdaq First North is Corpura Fondkommission AB, firstname.lastname@example.org, +46 (0)768-532 822. For more information about Alzinova, please visit: www.alzinova.com.