2:13AM Incyte presents positive results from proof-of-concept Phase II clinical trial of Oral JAK1 Inhibitor in patients with active rheumatoid arthritis (INCY) 39.43 : Co announces results from a 12-week, placebo-controlled, dose-escalation Phase II proof-of-concept clinical trial involving 60 patients with active rheumatoid arthritis for its proprietary oral JAK1 inhibitor.In this initial Phase II trial, 12 weeks of treatment with INCB39110 showed efficacy at all doses as measured by ACR 20, ACR 50, ACR 70, and DAS 28 as compared to placebo. Clinical benefit was observed as early as one week of treatment, and the highest dose tested, once-daily 600 mg, appeared to be the most effective dose.
Safety
While larger patient populations and longer term exposure are needed to fully explore the safety profile of INCB39110, at all doses evaluated in this trial, the compound was generally well-tolerated without evidence of myelosuppression or immunosuppression. Additionally, all treatment-emergent AEs were mild to moderate in intensity; there were no drug related serious adverse events, and no serious related or unrelated infections. Mean values for evaluated safety measures, including hemoglobin, neutrophil count, platelet count and lymphocyte count, remained stable and within normal range across the 12 weeks of the study.
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