Toleranzia starts toxicology study of its lead drug candidate TOL2
26 September - 2023
Toleranzia AB ("Toleranzia" or the "Company") today announces that it has started the regulatory GLP-toxicology study of its drug candidate TOL2. The study is conducted by Toleranzia´s partner Charles River Laboratories (CRL) in France.
The study constitutes a critical piece of the preclinical documentation required for the clinical trial application to regulatory authorities, to seek permission to initiate the upcoming first-in-human clinical study in myasthenia gravis patients. In the Good Laboratory Practice (GLP) toxicology study animals will be receiving daily doses of TOL2 on multiple days, mimicking the intended clinical treatment regimen, to determine the safety and tolerability of TOL2. Prior to this regulatory study, CRL conducted a short-term exploratory study in a small number of animals to establish that 10-fold higher doses of TOL2 than previously tested in efficacy studies in the myasthenia gravis disease model were safe and well tolerated.
“I am pleased to announce that the regulatory GLP-toxicology study of our drug candidate TOL2 has been initiated to evaluate the safety and tolerability characteristics of the drug product. Following a successful outcome of the study, we will have achieved a key milestone before starting clinical studies in patients.” comments Charlotte Fribert, CEO of Toleranzia.
For further information, please contact:
Charlotte Fribert – CEO, Toleranzia AB
Tel: +46 763 19 98 98
About Toleranzia AB (publ)
Toleranzia AB (publ) develops drugs that harness the power of the immune system for the treatment of autoimmune orphan diseases. The drugs, which target the cause of the disease, can cure or significantly alleviate the disease and not, like current treatments, merely reduce the symptoms. They have the potential to be the first long-acting or curative therapies that act specifically on the underlying cause of the autoimmune orphan disease for which they are being developed. Toleranzia's shares are listed on the Nasdaq First North Growth Market and Mangold Fondkommission AB, 08-503 015 50, CA@mangold.se, is the company's Certified Adviser.