Date: 2015-05-07
Type of information: Presentation of results at a congress
phase: preclinical
Announcement: presentation of results at the Respiratory Drug Delivery (RDD) Europe 2015 Conference (Nice, France, May 5-8)
Company: Ablynx (Belgium)
Product: ALX-0171
Action
mechanism: ALX-0171 is a Nanobody product which binds to RSV and neutralizes the virus. This trivalent molecule is the first Nanobody to enter the clinic that will be administered through inhalation instead of injection. It nhibits RSV replication and neutralises RSV activity by blocking virus uptake into cells. The physical robustness of the Nanobody allows administration via inhalation directly to the site of infection, i.e. the respiratory tract including the lungs. ALX-0171 has shown a potent anti-viral effect against recent clinical RSV isolates. The Nanobody was well tolerated in multiple Phase I clinical studies in adults.
Disease: Respiratory Syncytial Virus (RSV) infection
Therapeutic area: Infectious diseases - Respiratory diseases
Country:
Trial details:
Latest
news: * On May 7, 2015, Ablynx presented an overview of its unique and versatile Nanobody platform and its application for inhaled biological medication at the Respiratory Drug Delivery (RDD) Europe 2015 Conference (Nice, France, May 5-8). The presentation focused on Ablynx\'s wholly-owned, innovative, anti-RSV inhaled Nanobody therapeutic, ALX-0171, which is being developed for the treatment of established RSV infections in the general paediatric population. In vitro studies have demonstrated that ALX-0171 is potent and shows superior virus neutralisation. The robustness of the Nanobody also allows administration via inhalation, enabling delivery of ALX-0171 directly to the site of viral infection (i.e. the respiratory tract, including the lower airways) where it inhibits viral replication and neutralises viral activity by blocking virus uptake in the cells. In vivo proof-of-concept with ALX-0171 has been achieved using a neonatal animal model, demonstrating that daily inhalation of the Nanobody for three consecutive days in animals with established infection, resulted in a marked reduction of symptoms of illness, viral titres and RSV-associated lung pathology. Clinically, ALX-0171 has been shown to be well tolerated in more than 100 adults, including subjects with sensitive (hyper-reactive) airways. In December 2014, Ablynx initiated a first-in-infant Phase IIa study in the Northern Hemisphere to evaluate the safety, tolerability and clinical activity (including effect on feeding, respiratory rate, wheezing, coughing, general appearance and clinical scores) of inhaled ALX-0171 in otherwise healthy infants (aged 3-24 months) diagnosed with RSV and hospitalised for a lower respiratory tract infection. The lead-in part of the study with five infants has been successfully completed and recruitment is now on-going for the placebo-controlled part of the trial for which it is intended to recruit a total of 30 infants. Recruitment for this latter phase already started in the Northern Hemisphere but the RSV season has now finished there and preparations are currently on-going to open clinical study centres in the Asia-Pacific region where the RSV season occurs later in the calendar year. The goal is to complete recruitment by the end of 2015 with results expected during the first half of 2016.
