358/365 – Trial for myasthenia vaccine launches

At the end of December I received a press release from Curavac. The company representative said he had come across my blog on the vaccine and wanted to provide an update on its progress.

The Myasterix consortium launched the first phase of the clinical trial at the end of December. The firm said it ‘study will evaluate the safety, immunogenicity, and also explore the efficacy of a therapeutic vaccine candidate (coded CV-MG01) with 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’.

It will be randomised, double-blind, placebo-controlled and includes a dose escalation. The study will be carried out on 32 MG patients and comprises 2 parts. These are: an active part that lasts 5 months and an observational part that lasts 2 years to assess long-term treatment effects.

Dr. Stephane Huberty, Managing director of CuraVac, says: “We are delighted we can now start this long-awaited clinical trial for our MG therapeutic vaccine. We hope that this trial will go beyond showing that we can significantly improve the life of MG patients and that it will open the door for a new class of therapies applicable to other autoimmune diseases.”

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

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