AbbVie has started a Phase I clinical trial of a fully human SARS-CoV-2 neutralising antibody, ABBV-47D11, for treating adults hospitalised with Covid-19.
The antibody targets the virus spike protein’s conserved region.
AbbVie licensed the 47D11 programme from clinical-stage biopharmaceutical company Harbour BioMed (HBM) and Utrecht University (UU) in the Netherlands.
In the initial stage, AbbVie will carry out the clinical programme in the US and later expand it into Europe.
The randomised, double-blind, placebo-controlled study will analyse the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11 in adults hospitalised with Covid-19.
Three different doses of the antibody will be tested on 24 patients across study sites globally.
Study-drug related adverse events will form the trial’s primary endpoints and includes several other secondary outcomes.
Harbour BioMed principal founder, executive director, chairman and CEO Dr Jingsong Wang said: “The rapid progress we have made to date is a credit to the outstanding research by our teams and university partners, the strength of HBM’s fully human antibody discovery platform and AbbVie’s world-leading expertise in antibody and antiviral drug development.
“With the clinical programme at AbbVie now underway, we are in a position to contribute a new therapeutic option to address this pandemic.”
In pre-clinical studies, ABBV-47D11 demonstrated potential against SARS-CoV-2, as well as a related virus, SARS-CoV-1.
Under the licence agreement, HBM and UU will receive a one-time licence fee, payments upon reaching of certain development goal, regulatory and sales-based milestone, as well as tiered royalties on net sales of the antibody.
With the deal, AbbVie gained worldwide rights for development, manufacture, and commercialisation of ABBV-47D11.