Ablynx announced that it has completed target enrollment of the first-in-infant Phase I/IIa safety study with its anti-RSV Nanobody, ALX-0171, a wholly-owned Nanobody drug candidate, administered through inhalation, for the treatment of respiratory syncytial virus (RSV) infection in infants.1-24 months old.
Respiratory syncytial virus is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in babies and young children worldwide, resulting in an estimated 3,000-8,500 deaths annually. In addition, RSV infections have been linked to an increased risk of asthma development later in life Current treatment of RSV infection is primarily focused on symptomatic relief, hence the need for an effective and specific anti-RSV therapeutic.
Ablynx opened recruitment in December 2014,for the first-in-infant Phase I/IIa safety study with inhaled ALX-0171 in otherwise healthy infants diagnosed with RSV and hospitalized for lower respiratory tract infection. The study has recruited 35 babies in several clinical in Europe and the Asia-Pacific region, and consisted of 2 parts. The 1st was a lead-in phase with 5 infants who received inhaled ALX-0171, once a day for 3 consecutive days, while the 2nd consisted of a placebo-controlled phase in 30 infants who received either placebo or inhaled ALX-0171, once daily, for the same period of time. The primary endpoint of the study is safety and tolerability of ALX-0171. Secondary endpoints include clinical effect (including effect on feeding, respiratory rate, wheezing, coughing, general appearance and clinical scores), immunogenicity, pharmacokinetics (PK) and pharmacodynamics (PD) of inhaled ALX-0171.
Ablynx is a biopharmaceutical company in Ghent, Belgium, engaged in the development of Nanobodies(R), proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Presently, the Company has approximately 40 proprietary and partnered programs in development in various therapeutic areas including inflammation, hematology, immune-oncology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Genzyme, Merck & Co., Inc., Merck KGaA, Novartis, Novo Nordisk and Taisho Pharmaceuticals.
“Our company is pioneering the development of a potentially first-in-class treatment for RSV infection, an area of major unmet need, especially in infants, stated CEO Edwin Moses. We are looking forward to releasing top line results from this safety study in the first half of 20`6.