Ablynx reports positive Phase I data for ALX-0061 in rheumatoid arthritis
Ablynx announced positive Phase I data from the single ascending dose part of the Phase I/II study with ALX-0061, the anti-IL-6R Nanobody, in patients with rheumatoid arthritis (RA). Based on these positive interim data, Ablynx has initiated a multiple ascending dose Phase II study with ALX-0061 in patients with RA.
During the period April to September 2011, the Phase I study recruited a total of 28 RA patients who received either placebo or a single dose of ALX-0061, injected intravenously. The single doses ranged from 0.3 mg/kg to 6 mg/kg. The study treatment was safe and well tolerated, and the biological effective doses were achieved at the doses established in the pre-clinical studies. The dose-dependent changes of the assessed biomarkers of early inflammation (C-reactive protein, fibrinogen and platelets) were consistent with the inhibition of the IL-6 pathway.
Following this study, three doses were selected for the Phase II study, including 1 mg/kg every 4 weeks, 3 mg/kg every 4 weeks, and 6 mg/kg every 8 weeks. This proof-of-concept Phase II study, which has been initiated today, is expected to recruit 36 RA patients. A first read out, including efficacy measures (DAS, ACR scores) is anticipated after 12 weeks and a final read out, including biomarker responses, is planned after 24 weeks.
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