Ablynx initiates phase 1 pediatric respiratory trials
Belgian biopharma, Ablynx has initiated two additional phase 1 clinical trials with its anti- Respiratory Syncytial Virus (RSV) Nanobody, ALX-0171, with the goal of commencing paediatric development during the second half of 2014. The additional Phase I studies are being performed to determine the appropriate dosing regimen in the subsequent paediatric development of the Nanobody.
The results of both Phase I studies are expected during the first half of 2014.
“We are very pleased to move forward with our first inhaled Nanobody, which has the potential to become a first-in-class therapeutic to treat RSV infection in young children, an area with high unmet medical need. These additional studies will provide us with an appropriate clinical package for ALX-0171 that should allow the start of a Phase II study in infants during the second half of 2014.”
Dr Edwin Moses, Chairman and CEO of Ablynx.
RSV is the most common cause of bronchiolitis and pneumonia in children under one year of age, which is why there is a high need for an effective and specific anti-RSV therapeutic drug. It’s estimated that over 300,000 children are hospitalised each year in the seven major pharmaceutical markets and the reported infection rate is 70-80% in children under two years of age.
In addition, RSV infection is a significant cause of pulmonary disease in transplant patients, immune-compromised subjects and the elderly.
Ablynx has approximately 25 programmes in the pipeline and six Nanobodies at clinical development stage. The biopharmaceutical company has on-going research collaborations and significant partnerships with major pharmaceutical companies, such as Boehringer Ingelheim, Merck Serono, Novartis and Merck & Co.
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