Status update regarding application to start clinical study with ALZ-101Date: 2021-04-21
Alzinova announces today that the documentation required for the application to start the planned Phase 1b clinical study with the drug candidate ALZ-101 will be ready during June. As such, the first patient first dose (FPFD) will not be administered during this quarter as previously communicated.
The study is instead expected to start during the third quarter and we also plan to administer the FPFD in the same quarter, provided that the Covid-19 situation in Finland allows for that.
"Today's announcement means a slight change to what we have previously communicated, which is of course regrettable. However, we will soon have all the necessary documentation to apply to the Finnish Medicines Agency Fimea to start the study in Finland. We already have a positive statement from the Finnish ethics committee to start the study," says Kristina Torfgård, CEO of Alzinova.
For more information, please contact:
Kristina Torfgård, CEO
Telephone: +46 70 846 79 75
This information is information that Alzinova AB is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person in Swedish at 16:45 CEST on April 21, 2021.
About Alzinova AB
Alzinova AB is a Swedish biopharma company specializing in the treatment of Alzheimer’s disease 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 Growth Market is Corpura firstname.lastname@example.org +46 768-532 822. For more information about Alzinova, please visit: www.alzinova.com