Santhera Pharmaceuticals Holding Limited (OTCPK: SPHDF) closed at $3.7000 after increasing 51.02%, bringing its market cap to $13.54M. Recently, SPHDF stock traded 16.40K shares, a high volume compared to its average daily volume of 4.07K. SPHDF stock rose after a positive and statistically highly significant study concluded.
What was the purpose of the study?
Santhera is a Swiss specialty pharmaceutical company dedicated to identifying and developing new medicines for unmet medical needs in the field of rare neuromuscular diseases and respiratory diseases. The SPHDF has the exclusivity for all indications of vamorolone, a first-in-class dissociative steroid with a unique mechanism of action, which has been extensively studied as an alternative to standard corticosteroids in patients with DMD. The SPHDF has licensed exclusive North American rights to its first approved product, Raxone (idebenone), to Chiesi Group for the treatment of Leber’s hereditary optic neuropathy (LHON).
In a study known as VISION-DMD, Santhera and ReveraGen BioPharma, Inc yesterday announced positive results.
- Multiple efficacy endpoints were met in the study, suggesting vamorolone is an effective treatment option for patients with DMD and that it is safe and well tolerable as well.
- VISION-DMD is a pivotal Phase 2b study designed to demonstrate the efficacy and safety of vamorolone in the treatment of DMD in comparison with placebo and prednisone (active control).
- A 24-week double-blind study of 121 ambulant boys with DMD received vamorolone or placebo in the first 24 weeks.
- Further safety and tolerability data will be collected during a second study period of 24 weeks in which all participants are treated with either of the two dose levels of vamorolone.
Results of the study showed that:
Vamorolone scored higher than placebo in the study across multiple secondary endpoints. Vamorolone has been proven to be effective at dosages ranging from 2 to 6 mg/kg/day, based on clinical trials.