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
For further information, please contact:
Tel: +46 763 19 98 98
Email: charlotte.fribert@toleranzia.com
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