Toleranzia AB ("Toleranzia" or the "Company") today announces 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.
“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,” comments Charlotte Fribert, CEO of Toleranzia.
For further information, please contact
Charlotte Fribert - CEO, Toleranzia AB
Tel: +46 763 19 98 98
Email: charlotte.fribert@toleranzia.com
About Toleranzia AB (publ)
Toleranzia AB (publ) develops drugs that utilize the immune system's own power to treat autoimmune orphan diseases. The drugs, which target the cause of the disease, can cure or significantly alleviate the disease and not, like current treatments, only reduce the symptoms. They have the potential to be the first long-acting or curative treatments that act specifically on the underlying cause of the autoimmune orphan disease for which they are being developed. Toleranzia's shares are listed on Nasdaq First North Growth Market and Mangold Fondkommission AB, 08-503 015 50, CA@mangold.se, is the company's Certified Adviser.
TOLERANZIA AB 
