Daval International has reported positive results from a Phase II study, evaluating the safety and tolerability of Aimspro as a monotherapy to treat patients with late-stage established diffuse cutaneous systemic sclerosis.
Twenty paitents were enrolled in the double-blind, randomised and placebo-controlled study. They were given either Aimspro or placebo, 4.5mg/ml subcutaneously, twice weekly for 26 weeks.
The primary endpoint was to assess the safety and tolerability of the drug through the 26-week period.
The secondary measures included investigating the efficacy of Aimspro as a therapeutic agent for scleroderma using inter alia the Scleroderma Health Assessment Questionnaire, the Modified Rodnan Skin Score, the Scleroderma UK Functional Score, the Patient and Physician Global Assessment, the SF-36 and the MRC Sum Score.
At the end of the study, Aimspro was found to be a safe and well-tolerated medication when administered to systemic sclerosis patients at a late-stage of the disease.
Aimspro treatment combines the benefits of polyclonal antibody technology with polypeptide components.