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Ablynx NV Announces Positive Results of Phase I Study


Tuesday, 18 Sep 2012 01:30am EDT 

Ablynx NV announced that it has achieved positive results from a Phase I study with the first ever inhaled Nanobody, ALX-0171, a trivalent molecule which has been specifically designed by Ablynx for direct lung delivery, via a nebulizer, to treat respiratory syncytial virus (RSV) infections. The Phase I data showed that ALX-0171 could be successfully administered via nebulization directly into the lung in a clinical trial setting, confirming its potential as a first-in-class therapy to treat RSV infections. The stability of the Nanobody, together with its specific structure, small size and robustness, make this convenient route of administration possible and provides a potential solution to the pulmonary delivery of biologics where antibodies have been unsuccessful so far. The double-blind, randomized trial was conducted in healthy adult males to investigate the safety, tolerability and PK profile of ALX-0171. The Phase I study included a single-ascending dose part in 44 subjects, in which six dose levels ranging from 2.1 mg to 210 mg were tested. Subsequent, a multiple dose part was initiated in 16 healthy males, in which the subjects received ALX-0171, twice daily at a total daily dose of 140 mg and 210 mg respectively, for five days. The Phase I study results indicated that the Nanobody administration was well tolerated and did not induce any clinically relevant adverse events or clinically changes in lung function, at any of the dose levels tested.