Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce presentations of new data with vamorolone in Duchenne muscular dystrophy (DMD).
Cross-study comparisons of long-term efficacy, impact on growth velocity, and frequency and severity of spinal fractures for vamorolone versus current standard of care from the Phase 2b VISION-DMD study and the FOR-DMD study will be presented during the poster session at the 2022 Annual Conference of Parent Project Muscular Dystrophy (PPMD) to be held from June 23-26, 2022, in Scottsdale, AZ, USA.
“Data being presented by our academic collaborators at PPMD this year will provide further insight into our understanding of the potential of a dissociative steroid, such as vamorolone, in maintaining muscle strength whilst addressing important safety concerns such as preventing growth stunting and reducing the frequency and severity of bone related side effects such a spinal fractures in the treatment of Duchenne Muscular Dystrophy,” said Dr. Shabir Hasham, Chief Medical Officer and Head Global Medical Affairs of Santhera.
Propensity score matched populations from the pivotal Phase 2b VISION-DMD study and the FOR-DMD study compared the efficacy of vamorolone to prednisone and deflazacort over 48-weeks. Safety analyses focused on the comparison of the long-term endpoints of height and spinal fractures, with vamorolone data collected in study VBP15-LTE (long-term extension) [1] versus prednisone and deflazacort data from the FOR-DMD study [2] over 2.5 years.
Abstracts will be available on the PPMD website.
Santhera will be participating in the PPMD Resource Fair (June 23-24) at the conference where medical representatives of the Company will be onsite to provide scientific information and latest updates.
Santhera expects to complete the rolling new drug application (NDA) filing for vamorolone in DMD to the U.S. FDA in June 2022. Vamorolone has been granted Orphan Drug status in the US and in Europe for DMD, and has received Fast Track and Rare Pediatric Disease designations by the US FDA and Promising Innovative Medicine (PIM) status from the UK MHRA for DMD. Vamorolone is an investigational medicine and is currently not approved for use by any health authority.
