Ablynx posts strong data on key drug, looks set for approval
pharmafile | October 2, 2017 | News story | Research and Development, Sales and Marketing | Ablynx, biotech, drugs, pharma, pharmaceutical
In a major success for the European biotech industry, Ablynx has revealed that it had met the primary and secondary endpoints in a Phase 3 trial, making it look set to gain approval for its blood disease drug.
The drug, caplacizumab, is a treatment for the rare condition acquired thrombotic thrombocytopenic purpura (aTTP) and the data revealed a 74% reduction in aTTP-related death, recurrence of aTTP or at least one major thromboembolic event during treatment with its drug.
Additionally, the proportion of individuals that experienced recurrence of aTTP during the study was found 67% lower compared to those receiving placebo treatment.
In a further bonus to the drug, the safety profile was found to be extremely strong, with no major differences found between the drug and placebo treatment. The exception being a higher level of bleed-related adverse events, 66.2% against 49.3% in placebo – though they were noted to be mild or moderate in severity.
Dr Edwin Moses, CEO of Ablynx, commented: “I am delighted by this outcome as it reinforces all our beliefs in the potential for caplacizumab to change the lives of patients affected by aTTP. This is a very important milestone for the company as it further validates our Nanobody platform and demonstrates our ability to discover and develop medicines that make a real difference for society. These results strengthen our resolve to obtain marketing approval as quickly as possible so that caplacizumab rapidly becomes available to patients suffering from this severe disease for which there is currently no approved drug available.”
Ablynx has already applied for marketing authorisation the EMA and plans to file with the FDA in 2018. One of the major successes for the company is that the Belgium-based biotech has taken the treatment all the way through to Phase 3 by itself and now looks set to secure the potential peak sales of $400 million exclusively. It has already announced that it plans to market the drug with its own sales force.
European biotechs have, so far, lagged behind their counterparts across the Atlantic but this success will go some way to suggesting that it is possible within Europe to develop a company able to take treatments all the way through developmental stage to potential marketing authorisation.
Ben Hargreaves
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