Vamorolone clinical trial now fully recruited

 

It has been announced that ReveraGen’s Vamorolone phase 2a clinical trial has now finished recruiting - they have recruited the required 48 boys for the study. The trial is testing Vamorolone which is a 'designer steroid' with the potential to cause fewer side effects and produce greater benefits than other steroids which are commonly prescribed to slow the progression of Duchenne.

Six Australian boys are participating in the phase 2a trial (three in Melbourne and three in Sydney), which is designed to assess the safety and find the best dose of the drug. The boys are taking one of four different doses for two weeks followed by a two-week follow-up period. They will then be eligible to join an extension trial to continue to receive the drug for up to two years

A Phase 2b trial of Vamorolone is expected to start in late 2017 or early 2018, and will enrol about 100 boys with Duchenne at about 30 international sites. This study will be placebo controlled and will also involve comparison to traditional corticosteroids. The eligibility criteria for this trial hasn’t been announced yet.

Posted 10/25/2017