ABLX 23%
GHENT, Belgium, 2 October 2017 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced positive topline results from the Phase III HERCULES study with caplacizumab, the Company’s anti-von Willebrand factor (vWF) Nanobody® being developed for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).
Treatment with caplacizumab in addition to standard-of-care resulted in a statistically significant reduction in time to platelet count response (p<0.01), the primary endpoint of the study and a measure of prevention of further microvascular thrombosis. Patients on caplacizumab were 1.5 times more likely to achieve platelet count response at any given time point, compared to patients treated with placebo.
The Phase III HERCULES study also met the first two key secondary endpoints. Treatment with caplacizumab resulted in a 74% reduction in the percentage of patients with aTTP-related death, recurrence of aTTP, or at least one major thromboembolic event during study drug treatment (p<0.0001), with recurrences being the driver for achievement of this endpoint. In addition, the proportion of patients with a recurrence of aTTP in the overall study period (including the 28 day follow-up after discontinuation of study drug treatment) was 67% lower in the caplacizumab arm compared to the placebo arm (p<0.001), demonstrating the durability of the treatment effect.
Analysis of the third key secondary endpoint showed that no patients treated with caplacizumab were refractory to treatment compared to three patients treated with placebo (p=0.057).
The analysis of the fourth key secondary endpoint showed a trend to faster normalisation of the organ damage markers (lactate dehydrogenase, cardiac troponin I and serum creatinine) in patients treated with caplacizumab....
|
