Overview of vamorolone (VBP15) clinical trials

Vamorolone (VBP15): a steroid-alternative

Phase I single ascending dose study VBP15-001 (NCT02415439)

A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects

• Hoffman EP, Riddle V, Siegler MA, et al. Phase 1 trial of vamorolone, a first-in-class steroid, shows improvements in side effects via biomarkers bridged to clinical outcomes. Steroids 2018;134:43-52
Hoffman_2018_Steroids. Jun;134;43-52

• Mavroudis PD, van den Anker J, Conklin LS, et al. Population Pharmacokinetics of Vamorolone (VBP15) in Healthy Men and Boys With Duchenne Muscular Dystrophy. Journal of clinical pharmacology 2019
Mavroudis_2019_J Clin Pharmacol. Feb 11

 

Phase IIa dose-escalation study VBP15-002 (NCT02760264) and open-label extension study VBP-003 (NCT02760277)

A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

An Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

• Conklin LS, Damsker JM, Hoffman EP, et al. Phase IIa trial in Duchenne muscular dystrophy shows vamorolone is a first-in-class dissociative steroidal anti-inflammatory drug. Pharmacological research 2018;136:140-150

Conklin_2018_Pharmacol Res. Oct;136;140-150

 

Phase II long term extension study for VBP15-002 and VBP15-003 (VBP-LTE; NCT03038399)

Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

 

Phase II placebo-controlled study VBP15-004 (NCT03439670)

A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

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