Positive Results Presented From Proof-of-Concept Phase II Clinical Trial Of Incyte’s Oral JAK1 Inhibitor In Patients With Active Rheumatoid Arthritis

Incyte Corporation (Nasdaq: INCY) announced 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. These results were presented today at the 2013 American College of Rheumatology / Association of Rheumatology Health Professionals (ACR/ARHP) Annual Scientific Meeting being held in San Diego, CA, from Oct. 25 to 30, 2013.

“Along with our recently presented data with INCB39110 in psoriasis, results from this study in rheumatoid arthritis demonstrate the potential of JAK1 inhibition in inflammatory indications,” stated Richard S. Levy, Incyte’s Executive Vice President and Chief Drug Development and Medical Officer.

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. Below is a summary of the key efficacy endpoints evaluated at 12 weeks:
                 
       

Placebo N=12
      INCB039110
           

100 mg BID N=13
     

300 mg QD N=12
     

200 mg BID N=13
     

600 mg QD N=11
ACR 20, n (%)       4 (33)       7 (54)       6 (50)       6 (46)       10 (91)
ACR 50, n (%)       2 (17)       6 (46)       5 (42)       5 (39)       7 (64)
ACR 70, n (%)       1 (8)       4 (31)       1 (8)       2 (15)       6 (55)
                     
                 
       

Placebo N=12
      INCB039110
           

100 mg BID N=13
     

300 mg QD N=12
     

200 mg BID N=13
     

600 mg QD N=11
DAS 28 ESR

Mean score*
      5.4 (–1.2)       4.0 (–2.7)       3.9 (–2.5)       4.3 (–2.4)       3.1 (–3.2)
DAS 28 ESR< 2.6, n (%)       0 (0)       1 (8)       2 (17)       3 (23)       3 (27)
DAS 28 CRP

Mean score*
      4.8 (–1.1)       3.3 (–2.7)       3.2 (–2.4)       3.6 (–2.2)       2.7 (–2.9)
DAS 28 CRP< 2.6, n (%)       0 (0)       4 (31)       3 (25)       2 (15)       5 (46)

* Mean score at week 12 (change from baseline)
 

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. Mild increases were observed in ALT and AST during the first weeks of treatment. No patient developed a Grade 3 or Grade 4 abnormality or had an associated increase in bilirubin, which is consistent with enzyme induction. Increases in LDL and HDL were also noted, consistent with the expected effects of reduction of IL-6 signaling, without a significant change in the HDL/LDL ratio.

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