HCV agreement for Merck and BMS
pharmafile | April 23, 2013 | News story | Research and Development, Sales and Marketing | BMS, HCV, Merck
Merck & Co and Bristol-Myers Squibb have signed a non-exclusive agreement to conduct a Phase II trial looking at a combination of their investigational oral drugs to combat hepatitis C virus (HCV).
The programme will examine the safety and efficacy of a once-daily dose of BMS’s NS5A replication complex inhibitor daclatasvir, and Merck’s NS3/4A protease inhibitor MK-5172.
A Phase I safety evaluation of the combination has already been carried out and Merck will conduct the Phase II trial itself. What happens after that has yet to be decided, the companies admit.
“In HCV, agreements like this that combine novel investigational candidates are important to evaluate the potential of novel oral regimens early in the development cycle,” said Eliav Barr, vice president, infectious diseases, project leadership and management at Merck Research Laboratories.
Oral HCV regimens are attracting a great deal of interest from pharma companies, since they could be in line to take significant market share from existing injectable interferon treatments, which include Roche’s Pegasys and Merck’s PegIntron.
Daclatasvir is already in Phase III development and is being studied with Janssen’s NS3/4A protease inhibitor simeprevir (TMC435), among others.
Meanwhile MK-5172 is being studied with other drugs in Phase II, including with Merck’s own MK-8742, an investigational orally available HCV NS5A protease inhibitor.
Last year Janssen and GlaxoSmithKline announced they they were to conduct separate Phase II studies with Vertex Pharmaceuticals to test an investigational all-oral regimen.
Vertex’s nucleotide analogue HCV polymerase inhibitor VX-135 is to be used with simeprevir and GSK’s NS5A inhibitor GSK2336805.
They will seek to evaluate the safety, tolerability and viral cure rates of a 12-week regimen of GSK2336805 and VX-135, and simeprevir and VX-135 – administered with and without ribavirin – in treatment-naïve patients with chronic non-cirrhotic genotype 1 HCV.
Simeprevir, which was licensed by Janssen from Medivir, is already in Phase III trials such as QUEST-1 and QUEST-2, and the Vertex tie-up should throw some light on how it might work in different IFN-free treatment combinations and HCV patient populations.
It is being studied in combination with pegylated interferon and ribavirin, and with direct-acting antiviral agents in all-oral interferon-free regimens, with and without ribavirin.
Simeprevir is also being studied in other Phase II interferon-free trials with and without ribavirin in combination with:
- Janssen’s TMC647055 and ritonavir in treatment-naïve, relapser or null-responder HCV genotype 1 patients
- Gilead Sciences’ sofosbuvir (GS-7977) in null-responder HCV genotype 1 patients.
Two new hepatitis C drugs, Janssen’s own Incivo (telaprevir) and MSD’s Victrelis (boceprevir), were awarded the 2012 UK Prix Galien prize.
Both drugs inhibit the activity of the NS3/4A serine protease, the activity of which is essential for viral replication.
Adam Hill
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