Toleranzia has announced that the 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, states the company. 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.
We have met one of the most critical milestones in the TOL2 development program.”
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.
“I am pleased to conclude that with these positive results we have met one of the most critical milestones in the TOL2 development program. The data is fully in line with our expectations and allows us to move forward with the work to submit a clinical trial application and, following its approval by applicable authorities, to initiate our first clinical study in patients with myasthenia gravis,” says Charlotte Fribert, CEO of Toleranzia.
Photo of Charlotte Fribert