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[1] (> 3 milion per year, infants < 5 years of age) and the primary viral cause of infant death[1] (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[2]. 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.

[1] Mazur et al, Lancet, 2015
[2] 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)

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