Janssen and GSK in hep C tie-ups
pharmafile | November 8, 2012 | News story | Research and Development, Sales and Marketing | GSK, Janssen, Vertex, hep C
Janssen and GlaxoSmithKline are to conduct separate Phase II studies with Vertex Pharmaceuticals to test an investigational all-oral regimen to treat hepatitis C (HCV).
Vertex’s nucleotide analogue HCV polymerase inhibitor VX-135 is to be used with Janssen’s NS3/4A protease inhibitor simeprevir (TMC435) and GSK’s NS5A inhibitor GSK2336805.
The separate Phase II studies are scheduled to start early next year, subject to regulatory agreement.
“We are focused on the development of new all-oral treatments for hepatitis C that have the potential to provide a high cure rate with only 12 weeks of treatment,” said Vertex chief medical officer Robert Kauffman.
The Phase II studies 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.
Anti-HCV pills could be in line to take significant market share from existing injectable interferon treatments, which include Roche’s Pegasys and Merck’s PegIntron.
“There is a significant unmet need for all-oral treatment regimens for people living with hepatitis C,” said Wim Parys, global head of infectious diseases at Janssen.
Both agreements are based on joint funding of development costs, with no upfront or milestone payments.
Simeprevir, which was licensed by Janssen from Medivir, is already in Phase III trials such as QUEST-1 and QUEST-2, and Parys said the tie-up with Vertex will allow researchers to see how it might work in different IFN-free treatment combinations and HCV patient populations.
The drug 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
- Bristol-Myers Squibb’s daclatasvir (BMS052) in treatment-naïve or previous 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.
HCV is an area in which many companies are attempting to develop drugs, although there are risks.
In September Vertex abandoned development of its investigational adenosine nucleotide analogue ALS-2158, developed with Alios BioPharma, because of “insufficient antiviral activity to warrant proceeding”.
And Bristol-Myers Squibb admitted recently that the death of a patient was behind its decision to stop development of a potential treatment, the investigational nucleotide polymerase (NS5B) nucleotide BMS-986094.
Adam Hill
Related Content
GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis
GSK’s Exdensur (depemokimab), a twice-yearly biological medicine, has received approval from the UK Medicines and …
Vertex presents promising new data from cystic fibrosis trials
Vertex Pharmaceuticals has presented new data showing the clinical and quality-of-life benefits of its cystic …
Multiple myeloma treatment approved in Japan
GSK’s Blenrep (belantamab mafodotin) combinations have been approved by Japan’s Ministry of Health, Labour and …
