GHENT, Belgium, 3 May 2016 - Ablynx today announced positive top line results from the first-in-infant Phase I/IIa study of its wholly-owned, inhaled, anti-RSV Nanobody, ALX-0171, in 53 infants, aged 1-24 months, hospitalised as a result of a respiratory syncytial virus (RSV) infection.
The study met its primary endpoint, demonstrating the favourable safety and tolerability profile of ALX- 0171 when administered daily by inhalation in the target infant population, with no treatment-related serious adverse events reported.
ALX-0171 was detected in the serum of subjects after treatment, consistent with lung exposure. Anti-drug antibodies had no effect on the pharmacokinetics and no relation with adverse events was seen. Treatment with inhaled ALX-0171 had an immediate impact on viral replication and also reduced viral load, as compared to placebo. Analysis of a composite of clinical efficacy endpoints, the Global Severity Score1, led to an encouraging initial indication of a therapeutic effect for infants treated with ALX-0171.
Dr Robert K. Zeldin, CMO of Ablynx, commented: “We believe we are pioneers in the development of a treatment for infants infected with RSV, an area of significant unmet medical need. We are 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 anti- viral effect in RSV-infected infants and saw encouraging initial signs of clinical efficacy. We believe these results strongly support advancement into a Phase II efficacy study in infants.”
Dr Steve Cunningham, Department of Respiratory and Sleep Medicine, Royal Hospital for Sick Children, Edinburgh, UK, and Principle Investigator of the study, added: “RSV infection is the most common cause of lower respiratory tract disease leading to hospital admission in infants. It is often associated with continued coughing or wheezing after the acute phase of the infection and evidence is accumulating that it increases the risk of asthma later in life. There is no effective therapy available at present and the positive outcome from Ablynx’s first-in-infant study is therefore an important step forward in the development of an effective therapeutic for this serious infection.” |
