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Ablynx NV Updates on Phase II Part of Combined Phase I/II Study of Anti-IL-6R Nanobody, ALX-0061 Results


Wednesday, 13 Feb 2013 01:30am EST 

Ablynx NV (Ablynx) announced the efficacy and safety data for its anti-IL-6R Nanobody, ALX-0061, at the 24 week final analysis of the Phase II part of a combined Phase I/II study in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate. In this Phase II part, 37 RA patients were recruited and were randomized to three dose groups of intravenously administered ALX-0061 (1mg/kg Q4W, 3mg/kg Q4W and 6mg/kg Q8W) or to placebo. A total of 34 patients were eligible for determination of efficacy parameters at the 12 week interim period, and all these patients continued the study until week 24. Depending on the patient's disease status at week 10, the monthly dose was increased (from 1mg/kg to 3mg/kg; or from 3mg/kg to 6mg/kg) or the dosing regimen intensified (from 6mg/kg Q8W to 6 mg/kg Q4W), and patients on placebo could start monthly ALX-0061 treatment at 3mg/kg. The majority of patients (86%, N=24) completed the study at their ALX-0061 starting regimen (the 'unmodified' group), for 4 patients the dosing regimen was modified (the 'modified' group) and 3 patients were switched from placebo to ALX-0061 treatment (the 'switchers').