Idenix, Janssen begin phase 2 study of all-oral DAA therapy for HCV
Idenix Pharmaceuticals and Janssen Pharmaceuticals have begun enrollment in a phase 2 clinical trial to evaluate an all-oral, direct-acting antiviral combination for treatment of hepatitis C, according to an Idenix news release.
The 12-week HELIX-2 trial will analyze response to a combined treatment of samatasvir, a pan-genotypic NS5A inhibitor from Idenix; simeprevir, an NS3/4A protease inhibitor from Janssen R&D Ireland and Medivir AB; and TMC647055, an NS5B non-nucleoside polymerase inhibitor from Janssen, the release said.
The randomized, open-label trial will study treatment-naive HCV patients, as well as those who have relapsed after treatment with ribavirin and interferon. Patients will receive 50 mg samatasvir, 75 mg simeprevir and 450 mg TMC647055 boosted by 30 mg ritonavir once daily for 12 weeks, with or without ribavirin.
The trial is the second as part of a collaboration agreement between Idenix and Janssen. The HELIX-1 trial studying samatasvir and simeprevir is ongoing, the release said.
“We are pleased with the continuing progress of our clinical program for samatasvir, which will provide additional important information on the use of this promising compound as part of all-oral HCV combination regimens,” Doug Mayers, MD, Idenix’s chief medical officer, said in the release. “With the advancement of the samatasvir program, as well as that of our novel nucleotide prodrug inhibitor, IDX21437, we anticipate initiating the evaluation of our own HCV combination regimen in 2014.”
http://www.healio.com/infectious-disease/hepatitis-resource-center-2013/idenix-janssen-begin-phase-2-study-of-all-oral-daa-therapy-for-hcv
An all-oral phase IIa study combining Simeprevir, TMC647055 and JNJ56914845 in hepatitis C patients to be initiated
Stockholm, Sweden—Medivir AB (OMX: MVIR), announces the initiation of a phase IIa trial in chronic genotype 1 hepatitis C infected patients to evaluate the efficacy, safety and tolerability of a 12-week combination therapy of simeprevir, TMC647055 and JNJ56914845, a NS5A replication complex inhibitor.
Study design
Approximately 40 patients will be enrolled in this open-label study to assess the efficacy, safety and tolerability of the co-administration of simeprevir, TMC647055 and two different doses of JNJ56914845 without ribavirin. The trial will evaluate genotype 1a and 1b HCV-infected patients who are either treatment-naïve or who have relapsed after prior treatment with interferon and ribavirin. Patients will receive 75 mg of simeprevir, 30 or 60 mg of JNJ56914845 and 450 mg of TMC647055 plus a low dose of ritonavir as a pharmacokinetic enhancer, each once daily for 12 weeks.
For additional information about this study, please visit www.clinicaltrials.gov
For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292
Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 08.30 a.m. CET on 12 December 2013.
About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Medivir and Janssen R&D Ireland for the treatment of chronic hepatitis C infection in combination with other antivirals in HCV genotype 1 & 4 infected patients with compensated liver disease, including cirrhosis.
Simeprevir was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in the USA and Canada in November. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April 2013 by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.
About TMC647055
TMC647055 is a potent non-nucleoside hepatitis C polymerase inhibitor with broad genotypic coverage. TMC647055 is in phase II clinical development and is developed by Janssen R&D Ireland to treat chronic hepatitis C virus infections. TMC647055 is being investigated in combination with other DAA agents in all oral interferon-free regimens. There have been no treatment-emergent serious adverse events reported in the program.
About JNJ56914845
JNJ56914845, is a potent NS5A replication complex inhibitor. To date phase I and phase II clinical studies conducted demonstrated that JNJ56914845 60 mg once daily is well tolerated and produces rapid, substantial decreases in HCV RNA in treatment-naïve CHC subjects when given alone as a single dose and for 4 weeks in combination with pegIFN and RBV.
About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.
For more information about Medivir AB, please visit the Company’s website: www.medivir.com
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