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news.Daval International has reported that its double-blind placebo-controlled phase II clinical study to assess the safety and tolerability of Aimspro as a monotherapy in Established Diffuse Cutaneous Systemic Sclerosis (Scleroderma) yielded positive results.
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During the course of the trial, 4.5mg/ml doses of Aimspro was administered subcutaneously twice weekly for 26 weeks and its efficacy was evaluated as compared to a placebo.
The study demonstrated that the drug candidate proved to be a safe, well-tolerated medication and showed no deterioration in haematological, biochemical, immunologic, cardiologic or in pulmonary parameters.
The secondary endpoint comprises assessing the efficacy of Aimspro as a therapeutic agent for scleroderma using the Scleroderma Health Assessment Questionnaire, the Modified Rodnan Skin Score, the Scleroderma UK Functional Score, the Patient and Physician Global Assessment (VAS), the SF-36 (Short form 36) and the MRC Sum Score.