MYASTERIX phase 1b preliminary results communicated on 16 May
Press release: The preliminary results of Phase 1b clinical study of an active targeted immunotherapy at New York Academy of Science’s 13th International Conference on Myasthenia Gravis and Related Disorders
11th May, New York, U.S.A - The MYASTERIX consortium launched the Phase 1b clinical trial of an innovative antigen specific treatment that aims to provide significant and lasting improvement of Myasthenia Gravis (MG) in November 2015 at Antwerp University Hospital (UZA), Belgium. Prof. Rudy Mercelis, lead investigator of the trial at UZA, will present the results at the New York Academy of Science’s 13th International Conference on Myasthenia Gravis and Related Disorders in his presentation entitled A Phase 1b Clinical Trial of CV-MG01, Acetylcholine Receptor Mimetic Peptides on the 16th of May 2017 during the session on clinical trials.
The trial – Myasterix Phase 1b study (EudraCT 2015-002880-41) – aims to evaluate the safety, immunogenicity, and also explore the efficacy of an active targeted immunotherapy (coded CV-MG01) with designated orphan drug status in the USA by the Food and Drug Administration (FDA) and in Europe by the European Medicines Agency (EMA). CV-MG01 comprises two synthetic complementary peptides conjugated to a carrier protein. The MYASTERIX Phase 1b study is randomized, double-blind, placebo-controlled and includes a dose escalation. The study is being carried out on 24 MG patients and comprises 2 parts: an active part that lasts 5 months and an observational part for 2 years to assess long‐term treatment effects.
To date, Cohorts 1 and 2 of the study have been completed and Cohort 3 is currently underway. The study is monitored by a Data Review Committee which conducted a formal safety data review in August and then in December 2016. The second review was carried out based on data collected on the participants enrolled in Cohorts 1 and 2 of the study, as planned by the protocol. Participants in Cohort 1 (8 patients) received a low dose of the active substance CV-MG01 or a placebo while participants in Cohort 2 (8 patients) were given a high dose or a placebo, administered as three subcutaneous injections over approximately 3 months.
The findings of the review are very positive; no Serious Adverse Event (SAE) occurred. The reported Adverse Events (AE) were primarily injection site reactions (e.g. pain, small erythema and hardness at site of injection), mostly considered of mild severity with few moderate local reactions. These reactions resolved spontaneously after a few days.
The second data review also shows that the preliminary immunogenicity results and comparison of the two injection levels (low dose and high dose) suggest that the high dose has a greater immunogenic potential than the low dose. These results, including the preliminary efficacy results will be communicated at the 13th International Conference of Myasthenia Gravis and Related Disorders held by the New York Academy of Science from 15 to 17 May 2017.
Myasthenia Gravis (MG) is an acquired autoimmune disease that typically begins with ocular symptoms such as double vision and drooping eyelids, and then progresses to general weakness in the majority of the patients, involving facial muscles, speaking and swallowing, and limb and respiratory muscles. Symptomatic treatment, corticosteroid treatment, immunosuppressive drugs, and improved intensive care facilities have significantly improved treatment outcome, but still a large proportion of patients depend on long‐term immunosuppressive treatment, with potentially severe side-effects.
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 Center. The MYASTERIX project 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”.
About the MYASTERIX consortium:
The MYASTERIX consortium was formed on CuraVac’s initiative in 2012 and is supported by the European Union through a grant of €5.9 million under the Seventh Framework Programme for research, technological development and demonstration under Grant Agreement number 602420. The consortium aims to advance a therapeutic vaccine candidate - CV-MG01 with orphan drug status - for the autoimmune disease Myasthenia Gravis (MG) to human proof-of-concept studies. The project involves the manufacturing of the human formulation of CV-MG01 for clinical trials and the conduct of a Phase 1b study followed by a Phase 2b in MG patients. Partners of the MYASTERIX consortium are:
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