Date: 2012-09-18
Type of information: Results
phase: 1
Announcement: results
Company: Ablynx (Belgium)
Product: ALX-0171
Action
mechanism: ALX-0171 is a Nanobody product which binds to RSV and neutralizes the virus. ALX-0171 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 double-blind, randomised 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.
Latest
news: * On September 18, 2012, Ablynx 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 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. 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 Phase I study results indicated that the Nanobody administration was well tolerated and did not induce any significant clinically relevant adverse events or clinically significant changes in lung function, at any of the dose levels tested. In addition, no dose-limiting toxicity or treatment-emergent local or systemic immunogenicity was observed.
* On December 13, 2011, Ablynx has announced it has initiated a Phase I, 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.
