ABLYNX TO PRESENT A POST-HOC ANALYSIS OF THE PHASE II TITAN STUDY WITH CAPLACIZUMAB IN ACQUIRED TTP PATIENTS AT THE 21st CONGRESS OF THE EUROPEAN HEMATOLOGY ASSOCIATION

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Post-hoc analysis of the TITAN data showed that treatment with caplacizumab significantly reduced a composite endpoint of major thromboembolic events and mortality

GHENT, Belgium, 26 May 2016 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced that a post-hoc analysis of the worldwide Phase II TITAN study of its wholly-owned Nanobody®, caplacizumab, in patients with acquired thrombotic thrombocytopenic purpura (aTTP), will be presented at the 21st Congress of the European Hematology Association (EHA), being held from 9-12 June 2016 in Copenhagen, Denmark.

It has been previously reported that the efficacy and safety of caplacizumab in conjunction with the standard of care (plasma exchange) were evaluated in a Phase II study in 75 patients with aTTP. Caplacizumab was well-tolerated and the primary endpoint of a reduction in time to platelet normalisation was achieved with statistical significance (p= 0.005). In addition, during treatment, caplacizumab reduced aTTP recurrences by 71% compared to placebo when administered as an adjunct to standard of care[1].

Despite the current standard of care, mortality from an episode of acquired TTP is still reported to be up to 20% and patients remain at risk of life-threatening thrombotic complications. A post-hoc analysis of the Phase II data was performed to assess the impact of caplacizumab on a composite endpoint of major thromboembolic events and TTP-related mortality. The results demonstrate that a significantly lower proportion of subjects treated with caplacizumab experienced one or more major thromboembolic events, or died, as compared to placebo (11.4% versus 43.2%, nominal p-value of 0.006). These clinically meaningful results suggest that treatment with caplacizumab has the potential to reduce the major morbidity and mortality associated with acquired TTP.

The results from this post-hoc analysis will be presented during a poster presentation on 10 June 2016, from 17:15 to 18:45 CET (poster Hall H). The abstract (LB418): "Impact of caplacizumab treatment on mortality and major thromboembolic events in acquired TTP: Phase II TITAN study results", is available on the EHA website at www.ehaweb.org.

About caplacizumab and the TITAN study results

Caplacizumab is a highly potent and selective bivalent anti-von Willebrand Factor (vWF) Nanobody that received Orphan Drug Designation in the USA and EU in 2009. Caplacizumab inhibits the interaction between ultra-large vWF and platelets by targeting the A1 domain of vWF. It thereby prevents platelet aggregation and the formation of micro-clots during the acute, critical phase of acquired TTP.

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