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Ablynx RSV nanobody delivers positive results
June 2016
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GHENT, Belgium—Ablynx recently shared positive top-line results from its first-in-infant Phase 1/2a study of ALX-0171, its inhaled anti-RSV nanobody. The study consisted of 53 infants ages one to 24 months that had been hospitalized for respiratory syncytial virus (RSV) infection. The primary endpoint of a favorable safety and tolerability profile for ALX-0171 when administered via a daily inhalation was met, and in addition, no treatment-related serious adverse events were reported. Anti-drug antibodies displayed no effect on the pharmacokinetics, and treatment resulted in an immediate impact on viral replication, in addition to reducing viral load compared to placebo.
 
Dr. Robert K. Zeldin, chief medical officer of Ablynx, noted that the company is “very pleased that the positive safety and tolerability profile of our inhaled Nanobody observed in adults has now been confirmed in this vulnerable target population. In addition, we demonstrated ALX-0171’s marked antiviral effect in RSV-infected infants and saw encouraging initial signs of clinical efficacy. We believe these results strongly support advancement into a Phase 2 efficacy study in infants.”

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