X

About Us

Vamorolone was developed by a small core of ReveraGen employees (4 full time, 4 part time) working collaboratively with an international network of expert academic clinicians, and key clinical research organizations (CROs). The team effectively leveraged governmental support programs in both the US and EU, while collaborating effectively with international non-profit stakeholder foundations under a venture philanthropy model (shared risk, shared benefit agreements).

The public/private partnership model developed for the vamorolone development program enabled an unusual degree of clinical trial innovation in key respects:

  • Close engagement of parents of children affected by DMD throughout the vamorolone development program, including in clinical trial design, choice of primary outcome (time to stand from floor), and selection of clinical trial sites.
  • Extensive de-risking of the program throughout the development process, through peer review of both federal and foundation grant processes.
  • Strong engagement of clinical trial sites (academic physicians and their staff), through publication of newsletters, requests for feedback, and encouraging collaboration and publications.
  • Rapid and effective response to the COVID pandemic, with implementation of remote assessments through discussions with FDA, and quick implementation of these through extensive communications with clinical trial sites.
  • Innovations in biomarker studies. A keen attention to biomarker ‘context of use’ and ensuring that biomarker studies were ‘fit for purpose’ throughout the vamorolone development program.

The venture philanthropy business model will have long-lasting positive impacts on international muscular dystrophy foundations and the critical research and care support systems they provide. ReveraGen anticipates returning 2/3rd of all income from the sales and marketing of vamorolone to the international non-profit sector, so that the foundations can further invest in promising research leading to additional innovative therapies – in effect a “pay it forward” model.

ReveraGen’s confict of interest policy can be found here.