Vertex pursues parallel Hep C trialsVertex announced Thursday that it is pursuing two separate agreements that take a mix-and-match approach to pairing its polymerase inhibitor VX-135 with GlaxoSmithKline's NS5A inhibitor GSK2336805 and with Janssen's protease inhibitor simeprevir, also known as TMC435.
The agreements are completely separate, meaning no crossover between GSK and Janssen, but are similarly structured in that in each pairing, both partners cover the development costs, and there are no upfront milestone payments attached. Both also promise the possibility of being closer to an all-oral hepatitis C treatment. GSK's inhibitor is currently in Phase II testing and Janssen's simeprevir is in Phase III.
Regulators have to sign off on the Vertex-GSK and Vertex-Janssen trials before they kick off, and Vertex said in a statement that it expects to start the drug-drug interaction studies early next year.
Despite the Centers of Disease Control push to have all Baby Boomers screened for hepatitis C, the category has suffered several setbacks this year, including the shutdown of an experimental Bristol-Myers Squibb drug, triggered by the death of one patient and the hospitalization of several others, in addition to the February news that several patients in a Gilead clinical trial appeared to relapse.
Hepatitis C is contagious and can be either an “acute” form that may be a short term infection that can morph into a chronic infection, or it can be a chronic infection. The disease can cause liver problems as well as liver cancer, and the Centers for Disease control says 75% to 85% of acute infections become chronic cases. The CDC latest statistics estimate that about 3.2 million people have chronic hep C in the US, but notes that the number may be low, because many people do not know they are infected.