The Phase I study involves a single-centre, partially randomised, single-blind, placebo-controlled trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of intravenous and subcutaneous injections with the Nanobody in healthy subjects. The trial is expected to recruit 80 healthy volunteers and results are anticipated during H2 2014.
Dr Edwin Moses, Chairman and CEO of Ablynx commented: “We are very pleased that Boehringer Ingelheim has dosed the first healthy volunteers as part of our collaboration in Alzheimer’s disease which we started in 2007. The Nanobody’s progress into the clinic demonstrates their belief in its potential as a valuable treatment option for patients suffering from this complex disease for which no adequate drugs are currently available. It is the second of Ablynx’s partnered programmes that has entered clinical development this year and further enhances our pipeline which now contains seven Nanobody products at clinical development stage.”
In January 2007, Boehringer Ingelheim and Ablynx announced a worldwide research and licensing agreement to discover and develop new therapies for Alzheimer’s disease using Ablynx’s Nanobodies against a single disease target. The collaboration has a potential value of $265 million in upfront and milestone payments plus undisclosed royalties on product sales. Boehringer Ingelheim is solely responsible for the development, manufacturing and commercialisation of any products resulting from the collaboration.