CAMBRIDGE, Mass.—Vertex Pharmaceuticals Inc. has announced apair of non-exclusive agreements with GlaxoSmithKline (GSK) and JanssenPharmaceuticals, Inc. to conduct clinical studies on potential treatments forhepatitis C.
Under Vertex's non-exclusive agreement with GSK, thecompanies will conduct a Phase II proof-of-concept study of an all-oral regimenfor the treatment of hepatitis C. The treatment will consist of Vertex'snucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135 and GSK'sNS5A inhibitor GSK2336805, and the companies expect to initiate the study earlynext year. Vertex and GSK will jointly share the costs of the study, and thereare no upfront or milestone payments associated with the agreement. The study,to be conducted in the United States, will focus on treatment-naïve patientswith chronic non-cirrhotic genotype 1 hepatitis C, with primary goals ofdetermining the safety, tolerability and viral cure rates of multiple 12-weekcombination regimens of the two compounds, with and without ribavirin, one ofthe current standards of care for hepatitis C.
"This agreement underscores our broad commitment todevelop all-oral treatment regimens for people with hepatitis C using medicineswithin our own pipeline and by working in collaboration with other companieslike GSK who share our commitment to further improve treatment of thisdisease," Robert Kauffman, M.D., Ph.D., senior vice president and chiefmedical officer at Vertex, said in a press release. "We are focused on thedevelopment of new all-oral treatments for hepatitis C that have the potentialto provide a high cure rate with only 12 weeks of treatment, and we lookforward to the start of this study with GSK."
The agreement with Janssen falls along very similar lines.Per the non-exclusive collaboration, Vertex and Janssen will conduct a Phase IIproof-of-concept study of an all-oral hepatitis C treatment regimen combiningVX-135 and Janssen's protease inhibitor simeprevir (TMC435). Janssen willconduct a drug-drug interaction study with VX-135 and simeprevir to providesupport for the Phase II study, which is to begin in early 2013. The study willevaluate safety, tolerability and viral cure rates of a 12-week combination ofVX-135 and simeprevir. Development costs will be jointly shared, and no upfrontor milestone payments apply.
"This collaboration is an important step forward in ourcommitment to develop new all-oral treatment regimens for people with hepatitisC—both in collaboration with other companies like Janssen and with medicineswithin our own pipeline," said Kauffman. "We believe that an all-oralregimen of VX-135 and simeprevir has the potential to achieve high cure rateswith only 12 total weeks of treatment for people with hepatitis C, and we lookforward to the start of the Phase II proof-of-concept study with Janssen."
VX-135 is an investigational uridine nucleotide analoguepro-drug that inhibits hepatitis C virus replication by acting on the NS5Bpolymerase. In in-vitro studies, it wasshown to have a high barrier to drug resistance and demonstrated antiviralactivity across all genotypes of the virus. Vertex gained worldwide rights tothe compound through an exclusive licensing agreement with Alios BioPharma,Inc., which was signed in June of last year. In addition to the announcedcombination trials with GSK2336805, simeprevir and ribavirin, Vertex also plansto test VX-135 in combination with telaprevir, its approved protease inhibitor,which is currently marketed as INCIVEK for people with chronic genotype 1hepatitis C.
GSK's GSK2336805 is an investigational NS5A replicationcomplex inhibitor, and Janssen's simeprevir is a potent, once-dailyinvestigational hepatitis C protease inhibitor being jointly developed byJanssen R&D Ireland and Medivir AB.
SOURCE: Vertex press release
