Ablynx initiates additional Phase I studies with anti-RSV Nanobody ALX-0171

Activaero GmbH, the therapeutic area specialist for respiratory diseases focusing on novel, pharmacoeconomically meaningful treatment solutions, today announced that its partner Ablynx NV (NYSE Euronext Bruxelles: ABLX.BR) has initiated additional Phase I studies with its anti-RSV Nanobody ALX-0171 using Activaero's FAVORITE inhalation approach. Respiratory Syncytial Virus (RSV) is a pulmonary virus that infects the lungs and respiratory tract and is the most common cause of bronchiolitis and pneumonia in children under one year of age. The additional Phase I studies are being performed to determine the appropriate dosing regimen in the subsequent pediatric development of the Nanobody, which has the potential to become the first-in-class therapeutic in this indication.

Under a collaboration agreement, Activaero provides Ablynx with its flow and volume regulated inhalation technology (FAVORITE) - a drug delivery approach for local delivery of Ablynx's Nanobody ALX-0171 to the lungs, i.e. the site of infection. In contrast, it is very difficult to nebulize classical monoclonal antibodies because of their physiochemical properties. Consequently, these therapies are still administered systemically via injection or infusion and it has proved very difficult to deliver sufficient antibody to the infection site to achieve a therapeutic effect. However, Ablynx's Nanobody technology, which enables unique and flexible drug formatting, resulted in the creation of a highly potent trivalent Nanobody. The physical robustness of that Nanobody allows for fast delivery directly into the lungs via nebulization, resulting in a therapeutic effect specifically at the site of infection. A Phase I safety study in healthy male volunteers already demonstrated that single and multiple inhalations of the ALX-0171 were well tolerated and no dose-limiting toxicity or treatment emergent immunogenicity was observed. Furthermore, ALX-0171 had no clinically relevant effect on lung function, no signs of bronchoconstriction were observed, and the Nanobody provided the opportunity for once-daily dosing.

"The results achieved to date in the ALX-0171 development program by our partner Ablynx are very encouraging and represent further validation not only for Ablynx's unparalleled Nanobody technology, but also for Activaero's FAVORITE inhalation approach", commented Gerhard Scheuch, Founder and Chief Executive Officer of Activaero GmbH. "Activaero's approach ensures efficient and pharmacoeconomically beneficial drug delivery into the lungs. In particular in children, we have shown in a Phase II trial in which we treated asthmatic infants that we have a highly appropriate inhalation approach with short treatment times for this fragile patient population. That's essential for small children and infants, who are otherwise not able to focus on performing an optimal inhalation process."