ALX-0171 is a first-in-class inhaled Nanobody® developed for the treatment of RSV infections. The drug was found to be safe and well tolerated in a Phase IIa study in hospitalized infants with a RSV infection. Additionally, ALX-0171 had an immediate and significant impact on viral replication and an encouraging initial therapeutic effect in the Phase IIa study.
Ablynx today announced that it has dosed the first patient in the Phase IIb "RESPIRE" dose-ranging efficacy study of ALX-0171, its novel inhaled drug candidate to treat RSV infections. Topline results from this Phase IIb study of inhaled ALX-0171 are expected in the second half of 2018.
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. It is the primary cause of infant hospitalization and virus associated deaths in infants, with estimated global annual infection and hospitalization rates of 34 million and 3-4 million respectively. Current treatment of RSV infections is primarily focused on symptomatic relief, hence the need for an effective and specific anti-RSV therapeutic.
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This Phase IIb study is a randomized, double-blind, placebo-controlled, international, multicenter dose-ranging study of three different doses of inhaled ALX-0171 in approximately 180 infants (aged 1-24 months) diagnosed with RSV and hospitalized for a lower respiratory tract infection. ALX-0171 will be administered once daily for three consecutive days. The study consists of a sequential dose escalation part, which is expected to enroll approximately 36 infants, followed by a parallel part in which approximately 144 infants will be randomly assigned to one of the three dose groups of inhaled ALX-0171, or placebo.
The primary endpoint of the study is to evaluate the anti-viral effect of treatment measured in nasal swabs. Secondary endpoints include safety, pharmacokinetics, clinical activity with assessment of composite clinical scores such as the Global Severity Score (using data on feeding intolerance, medical interventions, respiratory distress, apnoea, general condition and fever), and time to clinical response (i.e. time needed to achieve adequate oxygen saturation and oral feeding ).
Dr Edwin Moses, CEO of Ablynx, commented: "Ablynx is a pioneer in the development of a specific treatment for RSV infections. The start of this efficacy study in hospitalized infants with a RSV infection is another important step forward. If recruitment goes to plan then the study is expected to be completed in the first half of 2018 with results anticipated by the end of 2018."