Myaware has been approached by CuraVac who are seeking people with myasthenia gravis to participate in a Phase 1b clinical trial. The trial is taking place at the Antwerp University Hospital (Belgium) and the organisers confirm that they will cover reasonable travel and accommodation expenses for selected participants. If you are interested in finding out more, please follow the link to contact the investigators directly as myaware is unable to provide any further information about this project.

The following text has been supplied by MYASTERIX

MYASTERIX Phase 1b Clinical Study to Test a Therapeutic Vaccine / Active Targeted Immunotherapy for Myasthenia Gravis is looking to recruit 2 patients to complete a study on 24 patients.

The MYASTERIX consortium is conducting a Phase 1b clinical trial of an innovative antigen specific treatment that aims to provide significant and lasting improvement of myasthenia gravis (MG). The study is evaluating the safety and immunogenicity, and also explores the efficacy of a therapeutic vaccine candidate (coded CV-MG01) with a designated orphan drug status in the USA and Europe by the FDA and the EMA. CV-MG01 comprises two synthetic complementary peptides conjugated to a carrier protein. 

The second formal safety data review carried out by the Data Review Committee based on data collected on the 16 participants enrolled in the first 2 cohorts of 8 patients was very positive as no Serious Adverse Events (SAE) occurred. The few Adverse Events (AE) observed, primarily injection site reactions (e.g. pain, small erythema and hardness at site of injection) were mostly considered of mild severity with very few moderate local reactions. These reactions resolves spontaneously after a few days (www.myasterix.eu/en/news-and-events).

The investigators are looking for an additional 2 patients to complete the 3rd cohort of 8 patients and reach the target of 24 patients included in the study.

The MYASTERIX Phase 1b study (EudraCT 2015-002880-41) is assessing the safety and immunogenicity, and explores the efficacy of CV-MG01 administered in three subcutaneous injections at weeks 1, 5 and 12. The study is randomised, double-blind, placebo-controlled and includes a dose escalation. The study is carried out on 24 MG patients and comprises of 2 parts, an active part that lasts 5 months and an observational part that lasts 2 years to assess long-term treatments effects. During the active part, participating patients have to spend 3 overnight stays following each MG Therapeutic Vaccine injection and come every 2 weeks (10 times including the inclusion visit) for a clinical assessment, during the observational part patients are asked to come every 4 months for a clinical assessment.

The MYASTERIX trial is sponsored by CuraVac Europe, a company based in Belgium and conducted at the Antwerp University Hospital (Belgium) in collaboration with the Leiden University Medical Centre (The Netherlands), Aepodia (Belgium & France), piCHEM (Austria) and Inserm Transfert (France). The trial is funded by the European Union's Seventh Framework Programme.

More information on the clinical trial can be found on www.clinicaltrials.gov website with the reference number NCT02609022 or by searching the keywords "Myasterix" or "CuraVac".

Interested patients can contact the investigators via[email protected] or via the dedicated telephone number +32 3 381 57 60.

Information: www.myasterix.eu
Contact: [email protected]