Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects

Multiple Ascending, Sequential, Placebo-controlled, Double-blind Study to Assess Safety, Tolerability and Efficacy of BVS857 in Severe Burn Subjects

Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15 weeks

No formal analysis was performed as study was terminated due to low enrollment issues. (n=1 patient was enrolled)

Inclusion Criteria:

• Burn injury comprising 2nd degree deep partial thickness and/or 3rd degree full thickness burns, ≥20% total body surface area with expected need for surgical intervention and not exceeding the sum of age plus burn size of 100 (Baux score)
• Dosing must occur within 8-12 days post-burn
• Subjects must weigh at least 45kgs (for group 1 with doses of 0.03mg/kg) and be under 100 kg to participate in the study

Exclusion Criteria:

• Spinal cord injury
• Hypoxic brain injury (Glasgow Coma Scale (GCS) <8) at screening
• True conductive electric burn with suspected neurologic injury
• Uncontrolled diabetes with HbA1c > 10% at screening, or known history of hypoglycemia,
• History of or active peripheral neuropathy or seizure disorder
• Systemic corticosteroids : > 10mg/d of prednisone or equivalent, other investigational treatments (excluding investigational dressings), medications for weight loss including megestrol acetate, androgens or oral beta agonists