Alzinova announces a delay in the supply of material for the clinical trial due to additional analytical work
Alzinova AB announces today that the manufacture of the drug substance for the Phase 1b clinical trial in Alzheimer's disease patients with the ALZ-101 vaccine has been delayed, as additional analytical work must be performed.
As previously disclosed, Alzinova has switched to a new supplier of the drug substance used for the ALZ-101 vaccine. According to plan, a technical batch of non-GMP (Good Manufacturing Practice) drug product was delivered on schedule during the second quarter. The purity of this batch was found to be higher than that of the drug substance produced by the previous supplier. The ongoing analysis of the technical batch has, however, not been completed in time, and the supply of material for the clinical Phase 1b study is thus delayed. The delivery of the drug for the study is now estimated to the first quarter of 2021. The study is expected to commence with the first patient’s first dose during the second quarter of 2021.
"The notification we received today is very unfortunate, and I can only say that I am disappointed that we were not able to adhere to the communicated timetable. Today's announcement means that we will not be able to initiate the clinical study during the fourth quarter this year as previously communicated. However, we are taking a positive view of the change in starting point to the second quarter of 2021, as it will likely facilitate patient recruitment in light of the anticipated covid-19 development," says Kristina Torfgård, CEO of Alzinova.
For more information, please contact:
Kristina Torfgård, CEO
Telephone: +46 70 846 79 75
E-mail: kristina.torfgard@alzinova.com
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 set out above at 8:01 am CEST on August 21, 2020.
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 info@corpura.se +46 768-532 822. For more information about Alzinova, please visit: www.alzinova.com