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Anabasum provides significant and “medically meaningful” efficacy in systemic sclerosis (SSc) as assessed by the American College of Radiology Combined Response Index in diffuse cutaneous Systemic Sclerosis (ACR CRISS) score and its individual domains, with acceptable safety and tolerability.
Why this matters
The results support continued clinical development of anabasum for the treatment of SSc.
Investigators compared treatment with anabasum versus placebo in 42 patients with disease duration ≤6 years who were on stable medication, including immunosuppressive drugs.
Subjects received anabasum 5 mg QD, 20 mg QD, or 20 mg BID on days 1-28 after which they received 20 mg BID on days 29-84 or placebo on days 1-84.
Patients were then followed while off the study drug on days 85-113.
The primary efficacy outcome was improvement in the ACR CRISS score, combined in the anabasum group versus placebo at the end of weeks 4-16. The five domains...