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A phase I/IIa trial of TOL-2 for the treatment of myasthenia gravis

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Trial Profile

A phase I/IIa trial of TOL-2 for the treatment of myasthenia gravis

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 23 Aug 2023

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At a glance

  • Drugs TOL 2 (Primary)
  • Indications Myasthenia gravis
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Toleranzia

    • Most Recent Events

    • 21 Aug 2023 According to a Toleranzia media release, the company announces that it has successfully completed the manufacturing steps of the GMP process for the TOL2 drug substance to be used in this trial. The GMP-grade drug product will subsequently be shipped to participating clinical centers.
    • 28 Mar 2022 According to a Toleranzia media release, the prospects of being able to start this study in the 2H2023 in accordance with the communicated schedule are strengthened, as the company has taken additional steps to secure access to the materials required to complete the scaleup of production and large scale manufacturing of TOL2; the Company has succeeded in finding an additional supplier and ordered, on behalf of its production partner 3P Biopharmaceuticals, all the purification material needed
    • 11 Nov 2021 According to a Toleranzia media release, the planned start of a first clinical study of its drug candidate TOL2 in patients with myasthenia gravis will be postponed until the second half of 2023 due to a continued global shortage of materials necessary for the purification of TOL2, which is also used in the prioritized manufacturing of covid-19 vaccines. The study was previously expected to be initiated before the end of 2022/23.
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