We’re pleased to share news from ReveraGen, the company developing the novel steroid alternative Vamorolone (previously called VBP15), that their drug has received Fast Track designation from the FDA, which will speed up the review of Vamorolone.
In 2014, Duchenne Research Fund, Duchenne UK and Joining Jack invested $1million in the successful Phase 1 study of VBP15, and we are delighted that it has now received fast track designation status at the FDA. Phase 2a and 2b trials of Vamorolone are due to start in the US and the UK this year.
As part of our commitment to making sure trials happen in the UK, the Duchenne Research Fund is also funding the Chief Investigator running the Vamorolone trial in the UK, Dr Michela Guglieri, together with Action Duchenne, Alex’s Wish, Duchenne Now, Duchenne UK, Joining Jack, and match funding from Newcastle University.
Please read the press release below for more information.
ReveraGen BioPharma Inc today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for Vamorolone (VBP15) for the treatment of patients with Duchenne muscular dystrophy. This designation can speed the review of efficacy and safety data for Vamorolone in boys with DMD, potentially leading to more rapid regulatory approval. Vamorolone is under parallel guidance from the FDA and the European Medicines Agency (EMA).
By granting this designation, FDA acknowledges that the Vamorolone program is directed towards development of a potential treatment for a serious condition, and addresses an unmet medical need. The VISION-DMD clinical trial program for Vamorolone is currently enrolling boys with DMD into clinical trials in US, Canada, Australia, Sweden, UK, and Israel (open label Phase 2a, Phase 2a extension, and Long-term extension studies). Blinded, placebo- and glucocorticoid-controlled Phase 2b trials are expected to initiate enrollment later this year.
An alternative to existing steroid treatments for Duchenne.