GHENT, Belgium, 6 May 2014 - Ablynx [Euronext Brussels: ABLX] today announced that it has obtained positive results from two additional Phase I studies, utilising its wholly-owned anti-RSV Nanobody® (ALX-0171) designed for the treatment of Respiratory Syncytial Viral (RSV) infections, following on from the successful Phase I study reported in September 2012. ALX-0171 is Ablynx’s first inhaled Nanobody and was administered to adults via a nebulizer in a safety study and in a pharmacokinetic (PK) study.
RSV is a virus which infects the respiratory tract. It is the most common cause of bronchiolitis and pneumonia in children under one year of age. ALX-0171 is a potential first-in-class therapeutic for RSV, an infection for which there is no widely accepted anti-viral treatment currently available. Ablynx expects to commence a proof-of-concept study in the target paediatric population with ALX-0171 in Q4 2014 with data due in 2015.
The safety study was performed in 24 adults with hyper-reactive airways using single escalating doses of ALX-0171, ranging from 2 to 200 mg, as well as repeated daily inhalation of either 140 or 200 mg of ALX-0171 for 5 days, to determine the occurrence and reversibility of bronchoconstriction (narrowing of the airways in the lungs). Bronchoconstriction may be induced by inhalation therapy and therefore it is important in the evaluation of any such therapy to determine whether bronchoconstriction can be reversed and/or prevented by standard bronchodilators.
The data generated from the safety study demonstrated that administration of the Nanobody was well-tolerated. As expected, some subjects experienced bronchoconstriction but the extent of this was limited (mild) and did not show any clear relationship to dosing. The event could immediately be reversed and subsequently prevented by the use of standard bronchodilators (ß2-agonists). Guidance can therefore be given in future trials on how to treat bronchoconstriction in the event that it occurs after treatment with ALX-0171.
The PK study was performed in 41 healthy adult volunteers and investigated the concentration of the Nanobody locally (in the bronchial and alveolar space) and/or systemically when administered by oral inhalation or intravenous administration. Direct measurement of ALX-0171 levels in the lung demonstrated very rapid attainment of clinically relevant levels after once-daily administration by inhalation. The lung exposure could be correlated with the systemic exposure and this, together with the desired target concentration and further PK modelling, will allow determination of the dose expected to be effective in infants.
Results from the PK study reconfirmed that ALX-0171 was well tolerated, as reported after the initial first-in-human study, at concentrations in the lung which are well above the levels that will be targeted in the forthcoming paediatric studies... |
