Date: 2014-05-06
Type of information: Results
phase: 1
Announcement: results of two additionnal studies
Company: Ablynx (Belgium)
Product: ALX-0171
Action
mechanism: ALX-0171 is a Nanobody product which binds to RSV and neutralizes the virus. This trivalent molecule is the first Nanobody to enter the clinic that will be administered through inhalation instead of injection.
Disease: Respiratory Syncytial Virus (RSV) infections
Therapeutic area: Respiratory diseases - Infectious diseases
Country:
Trial
details: 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). 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.
Latest
news: * On May 6, 2014, Ablynx has 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. Ablynx now 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 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 (Beta2-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. * On July 4, 2013, Ablynx has announced that it has initiated two additional Phase I studies with its anti-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, and will include a safety study in adults with hyper-responsive airways and a local and systemic pharmacokinetic (PK) study in healthy volunteers. The results of both Phase I studies are expected during the first half of 2014. Last September, Ablynx has announced positive results from a Phase I study with ALX-0171, which has been specifically designed by Ablynx for direct lung delivery, via a nebuliser, to treat respiratory syncytial virus (RSV) infections. The Phase I data showed that ALX-0171 could be successfully administered via nebulisation directly into the lung in a clinical trial setting, confirming its potential as a first-in-class therapy to treat RSV infections.
