Toleranzia AB contracts clinical CRO for the phase I/IIa study of TOL2
Toleranzia AB (“Toleranzia” or the “Company”) hereby announces that the Company today entered into an agreement with Clinical Trial Consultants (CTC), a clinical contract research organization (CRO) for the conduct of the Phase I/IIa clinical trial of TOL2 in patients with myasthenia gravis (MG).
Toleranzia is in the process of finalizing all documentation to submit a clinical trial application to the European Medicines Agency. As part of the preparations, the Company has today contracted a clinical CRO to be responsible for the conduct of the upcoming multicenter study of TOL2 in patients with MG, which is planned to be conducted in Sweden, Denmark and Germany. After an extensive review and evaluation of a large number of potential international CROs, the choice fell on the Uppsala-based company CTC, which has extensive knowledge and significant experience of the type of study that Toleranzia plans to conduct, as well as its own clinical unit where the Swedish part of the study can be conducted.
“We are very pleased to have entered into an agreement with CTC to conduct the Phase I/IIa study of TOL2 in patients with MG. CTC is a competent partner with extensive experience in conducting Phase I and Phase II studies and with a large network of clinical centers. We are now focusing on developing and shortly submitting the clinical trial application. Based on results from animal studies, TOL2 has shown great potential and we look forward to the significant step in TOL2’s development to initiate clinical studies in patients with MG”, comments Charlotte Fribert, CEO, Toleranzia.
“We are very honored and proud that CTC has been selected as CRO for Toleranzia to develop an innovative treatment for the autoimmune disease MG. Our expertise in Phase I and Phase II studies, together with our extensive network of clinical centers, positions us well to support the development of TOL2. We look forward to collaborating with Toleranzia’s skilled team and contributing to the success of this important First in Human study”, comments Anders Millerhovf, CEO, CTC.
For further information, please contact
Charlotte Fribert – CEO, Toleranzia AB
Tel: +46 763 19 98 98
E-mail: charlotte.fribert@toleranzia.com
About Toleranzia AB (publ)
Toleranzia AB (publ) develops medicines that harness the power of the immune system to treat rare autoimmune diseases. The drugs, which target the cause of the disease, can cure or significantly alleviate the disease and not, like current treatments, just reduce 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.