Toleranzia AB announced that the pivotal toxicology study, conducted under Good Laboratory Practice (GLP), to enable first-in-human clinical trials, has been completed. The drug candidate was well tolerated at the dose tested, a finding fully supporting continued development of TOL2 and the submission of an application for the initiation of clinical trials in patients with myasthenia gravis. The objective of the study was to determine the potential toxicity of TOL2, a tolerance-inducing recombinant protein developed for the treatment of myasthenia gravis, when given intravenously for ten days.

No adverse effects were observed during the treatment and follow-up periods. The GLP toxicology study which was initiated in September 2023 is now completed and Toleranzia has received the preliminary report from the study. In summary, the results demonstrate that TOL2 is well tolerated at the dose tested.