ALX-0171 – wholly-owned anti-RSV Nanobody to treat Respiratory Syncytial Virus (RSV) infection in infants
- RSV therapeutic administered via inhalation - major Nanobody platform advantage
- Most advanced product in clinical development to treat RSV infections in infants
- Critical pre-clinical (neonatal lamb model) and clinical (adult study and study in infants hospitalised with RSV infection) milestones achieved
- Phase IIb dose ranging efficacy study in infants planned to start in Q4 2016
Unmet need in RSV infection
RSV is the leading cause of infant hospitalisation (> 3 milion per year, infants < 5 years of age) and the primary viral cause of infant death (66,000-199,000 deaths, infants <5 years of age). RSV infection has also been associated with prolonged wheezing and an increased risk for asthma development later in life. However, there are no drugs specifically approved for the treatment of RSV infections. Hence, there is a high need for a specific and effective treatment for RSV infection in infants.
ALX-0171 unique route of administration
The physical robustness and stability of Nanobodies allows them to survive the extreme conditions needed for drug nebulisation. ALX-0171 is the first Nanobody treatment developed for delivery directly into the lungs by nebulisation, i.e. the site of RSV infection.
ALX-0171 mode of action
ALX-0171 (42kD) has first-in-class potential for the treatment of RSV infection. It is a trivalent, Nanobody that inhibits RSV replication by binding the F-protein on the virus’ surface and thereby neutralises RSV by blocking virus uptake into cells, allowing the host’s immune system to clear the virus.
 Mazur et al, Lancet, 2015
 Sigurs et al, Thorax, 2010; Backman et al, Acta Pediatr, 2014
Related presentations, abstracts and posters
Webcast presentation: Ablynx reports positive top line results for its inhaled anti-RSV Nanobody (ALX-0171) in a Phase I/IIa study in infants hospitalised with an RSV infection
3 May 2016 - Zwijnaarde, Belgium
Presentation: ALX-0171: safety, efficacy and therapeutic potential of an inhaled anti-RSV Nanobody (presented at the Respiratory Drug Delivery Europe 2015 Conference - 6 May 2015)
Presentation: A PB-PK model to explore ALX-0171 PK in infants following inhalation (presented at the Benelux Pharmacometric meeting – 27 November 2014)
Presentation: Delivery of ALX-0171 by inhalation greatly reduces disease burden in a neonatal lamb RSV infection model (presented at the 9th International Respiratory Syncytial Virus Symposium, 9-13 November 2014)
Poster presentation: A physiologically-based pharmacokinetic (PB-PK) model to explore ALX-0171 PK in infants following inhalation (presented at the fifth American Conference on Pharmacometrics – 12-15 October 2014)
Presentation: Development of ALX-0171, an inhaled Nanobody for the treatment of respiratory syncytial virus infection in infants (presented at Human Antibodies and Hybridomas Conference – 1 April 2014)