GHENT, Belgium – Ablynx [Euronext Brussels: ABLX] today announced that it has initiated a Phase I study in healthy volunteers with ALX-0171, the first Nanobody in clinical development to be delivered by inhalation. ALX-0171 is being developed for the treatment of respiratory syncytial viral (RSV) infections.
The Phase I study is a single-centre, randomised, placebo-controlled trial that will investigate the safety, tolerability and PK profile of ALX-0171 in healthy volunteers. The study will include a single ascending dose part with six dose levels, which is expected to recruit 44 subjects, followed by a multiple dose part that is expected to recruit 16 subjects. Results of the study are anticipated during the second half of 2012.
Dr Edwin Moses, CEO and Chairman at Ablynx, commented:
“We believe there is a high unmet need for a therapeutic treatment of RSV infection. ALX-0171 is the first Nanobody to enter clinical development that is administered through inhalation rather than injection. It has the potential to become a first-in-class therapeutic for RSV infections. This alternative route of administration in an acute disease setting is a good example of the competitive differentiation and advantages our Nanobody technology platform can bring. We are looking forward to seeing the results of this first-in-man trial, which are expected during the third quarter of 2012.”
RSV is a respiratory virus that infects the lungs and respiratory tract. Most healthy people recover from an RSV infection within one or two weeks. However, the infection can be much more severe in immune-compromised individuals, the elderly, infants with cardio-pulmonary disease and premature babies. RSV is the most common cause of bronchiolitis (inflammation of the bronchioles, the smallest air passages of the lungs) and pneumonia in children younger than one year old, and is increasingly being recognised as an important cause of respiratory illness in the elderly. Today, there are no widely accepted established antiviral agents available for the treatment of RSV. High-risk infants can be protected with a prophylactic drug that is used to protect against RSV infections. ALX-0171 has the potential to become a first-in-class therapeutic for the treatment of RSV and may address an even larger patient population beyond high-risk infants in the therapeutic setting.