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Ablynx Reveals Positive Results From Phase III HERCULES Study With Caplacizumab

Ablynx (ABLYF.PK) announced Monday positive topline results from the Phase III HERCULES study with caplacizumab, being developed for the treatment of acquired thrombotic thrombocytopenic purpura or aTTP.

The treatment with caplacizumab, the company's anti-von Willebrand factor or vWF Nanobody, in addition to standard-of-care resulted in a statistically significant reduction in time to platelet count response, the primary endpoint of the study, the company noted. It is also 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, 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 was 67% lower in the caplacizumab arm compared to the placebo arm, demonstrating the durability of the treatment effect.

The company added that 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.

The analysis of the fourth key secondary endpoint showed a trend to faster normalisation of the organ damage markers in patients treated with caplacizumab.

Based on the topline data, the safety profile of caplacizumab is consistent with its mechanism of action and the Phase II TITAN study results.

Ablynx said the latest reported data will be used to support the registration process for the caplacizumab in Europe and the USA.

Robert Zeldin, Chief Medical Officer at Ablynx, said, "Patients with aTTP are at risk for significant morbidity and early death. We believe these positive Phase III study results confirm the potential for caplacizumab to address the high unmet medical need in the treatment of aTTP and to have a meaningful impact on the lives of affected patients. We continue to analyse the data and look forward to sharing the results with regulatory authorities and the scientific community."

by RTTNews Staff Writer

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