Date: 2012-11-01
Type of
information: Initiation of the trial
phase: 2
Announcement: initiation of a trial
Company: Medivir (Sweden) Janssen (J&J - USA) Vertex Pharmaceuticals (USA - MA)
Product: simeprevir (TMC435) and VX-135
Action
mechanism:
- direct-acting antiviral agent/protease inhibitor/RNA polymerase (NS3A) inhibitor
- Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir.
- VX-135 (ALS-2200) is a uridine nucleotide analogue pro-drug that appears to have a high barrier to drug resistance based on in vitro studies. It is designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase. In vitro studies of the compound showed antiviral activity across all genotypes, or forms, of the hepatitis C virus, including genotypes more prevalent outside of the United States.
Disease: hepatitis C
Therapeutic
area: Infectious diseases
Country:
Trial
details:
Latest
news:
- Medivir has announced plans for a phase II proof-of-concept study of an all-oral regimen for the treatment of hepatitis C containing of Medivir/Janssen’s protease inhibitor simeprevir and Vertex’s nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135. Janssen will conduct a drug-drug interaction study with simeprevir and VX-135 to support the planned initiation of a phase II proof-of-concept study in early 2013, pending discussions with regulatory authorities.
The phase II study is expected to evaluate safety, tolerability and viral cure rates using a 12-week combination of simeprevir and VX-135, with and without ribavirin. Janssen and Vertex will jointly fund development costs associated with the collaboration. There are no up-front or milestone payments associated with the agreement.
Vertex and Janssen expect to initiate a phase II proof-of-concept study of VX-135 and simeprevir in early 2013, following the completion of a drug-drug interaction (DDI) study. Costs associated with the studies will be shared equally between the two companies. The goals of the study will be to evaluate safety, tolerability and viral cure rates of multiple 12-week combination regimens (SVR12*) of VX-135 and simeprevir, with and without ribavirin. The study will include patients who have chronic non-cirrhotic genotype 1 hepatitis C and have not previously been treated (treatment-naïve). Additional information on the phase II study will be provided upon initiation of the study.
* SVR12 = undetectable hepatitis C virus 12 weeks after the end of treatment.
Is
general: Yes
