ABLYNX’S ANTI-IL-6R NANOBODY, ALX-0061, SHOWS EXCELLENT 24 WEEK SAFETY AND
EFFICACY RESULTS IN A PHASE II CLINICAL TRIAL IN RHEUMATOID ARTHRITIS
ACR20, ACR50 and ACR70 scores of up to 100%, 75% and 63% respectively
Up to 75% of patients in DAS28 remission
Attractive safety profile at all administered doses
No anti-drug antibodies detected
No disease progression as determined by MRI radiography
GHENT, Belgium, 13 February 2013 - Ablynx [Euronext Brussels: ABLX] today announced 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 randomised to three dose groups of
intravenously administered ALX-0061 (1mg/kg Q4W1, 3mg/kg Q4W and 6mg/kg Q8W1) 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 vast 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’).
At all doses tested, ALX-0061 was well-tolerated and the safety profile compared favourably to data
reported for other biological DMARDs2. No clinically relevant neutropenia (moderate or severe decrease
in neutrophils, a type of white blood cell), no clinically significant increases in lipid levels (cholesterol and
triglycerides) were observed, and there were no serious infections. Infrequent elevation of liver enzymes
were reported; the events were transient, generally mild to moderate, and did not result in a
discontinuation of the treatment. Additionally, the side effect profile of ALX-0061 did not change with
increased dose or treatment duration and no anti-drug antibodies were detected...
hugin.info |
