Merck Serono has started dosing healthy volunteers in a Phase I trial designed to assess the nanobody, ALX-0761, for the treatment of inflammatory diseases.
ALX-0761 is the first investigational candidate co-developed by Merck Serono and Ablynx under a collaboration agreement signed in 2008.
The single-centre, placebo-controlled trial will evaluate the safety, pharmacokinetic and pharmacodynamic profile of single ascending doses of subcutaneous ALX-0761 injections.
Ablynx chairman and CEO Dr Edwin Moses said the first programme with Merck Serono was advancing into clinical development in less than five years of collaborating.
"We have now reached the point at which we will rely on Merck Serono’s considerable resources and expertise to take this programme forward," Moses said.
"We remain committed to continue to work closely with our partner not only on ALX-0761 but on the other four co-discovery and co-development programmes where we are currently collaborating."
As per the terms of the collaboration deal, Ablynx opted to convert the co-discovery and co-development collaboration into a licence agreement, with Merck Serono holding an exclusive worldwide licence for ALX-0761.
In exchange, Ablynx will earn additional development milestone payments upon the advancement of the product in multiple indications, regulatory and commercial milestones, in addition to royalties based on the product approval.
In addition, the starting of the randomised, double-blind, Phase I study triggered a milestone payment worth €2.5m to Ablynx.
Image: Micrograph showing acute inflammation of the prostate gland with the characteristic neutrophilic infiltrate. H&E stain. Photo: courtesy of Nephron.