Janssen Pharmaceuticals and Vertex Pharmaceuticals have entered into an exclusive licence agreement to develop, manufacture and commercialise VX-787, an investigational medicine for treatment of influenza A.
VX-787 is an influenza A-specific, oral polymerase inhibitor developed to directly inhibit replication of the influenza A virus, including recent H1 and H5 influenza strains, based on in-vitro data.
Under the terms of the licensing agreement, Janssen also has the rights to develop, manufacture and commercialise VX-787’s back-up compound, VX-353, for treatment of influenza. Janssen has additional rights for these activities for certain other back-up compounds for treating and preventing this disease.
VX-787 is currently in Phase II development and Vertex completed a Phase IIA study of VX-787 in 2013. The Phase IIA challenge study showed statistically significant improvements in viral and clinical measurements of influenza A infection and demonstrated clinical proof-of-concept.
Janssen and Vertex anticipate additional clinical trials to begin in the coming months.
Janssen infectious diseases and vaccines global therapeutic area head Johan Van Hoof said: "This treatment has the potential to address a significant unmet medical need and to improve the well-being of patients everywhere."
According to Vertex, VX-787 has showed potent and rapid in-vitro antiviral activity on all the company tested influenza A strains to date, including oseltamivir (Tamiflu) resistant strains. Initial clinical assessments of VX-787 have also been promising.
In Phase I studies, the molecule was well-tolerated in healthy volunteers providing a pharmacokinetic profile supportive of once-daily dosing.
