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Study Results For PPI668 NS5A, BI335 protease, BI127 non-nuc polymerase - new collaboration between Presidio & Boerhinger Ingelheim
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Presidio Pharmaceuticals Announces Collaboration with Boehringer Ingelheim
The Parties to Initiate a Phase IIa Trial of an All-Oral Combination of Presidio's HCV NS5A inhibitor (PPI-668) with Faldaprevir (BI201335) and BI207127 for the Treatment of Patients with Hepatitis C
PPI-668, A Potent New Pan-Genotypic HCV NS5A Inhibitor: Phase 1 Efficacy and Safety
http://www.natap.org/2012/AASLD/AASLD_34.htm
SVR4 and SVR12 with an interferon-free regimen of BI 201335 AND BI 207127, +/- ribavirin, in treatment-na夫e patients with chronic genotype-1 HCV infection: Interim results of SOUND-C2
http://www.natap.org/2012/EASL/EASL_38.htm
Virologic response to an interferon-free regimen of BI 201335 and BI 207127, with and without ribavirin, in treatment-na夫e patients with chronic genotype-1 HCV infection: Week 12 interim results of the SOUND-C2 study
http://www.natap.org/2011/AASLD/AASLD_19.htm
Treatment with the 2nd generation HCV protease inhibitor BI 201335 results in high and consistent SVR rates - results from SILEN-C1 in treatment-na夫e patients across different baseline factors
http://www.natap.org/2011/AASLD/AASLD_23.htm
STARTVerso 4: High rates of early virologic response in HCV genotype 1/HIV-co-infected patients treated with faldaprevir plus pegIFN and RBV
http://www.natap.org/2013/CROI/croi_02.htm
CROI: Pharmacokinetic interactions of darunavir/ritonavir, efavirenz, and tenofovir with the HCV protease inhibitor faldaprevir in healthy volunteers - (03/04/13)
CROI: Boerhinger Ingelheim Announes Interim Results Evaluating Virologic Response Rates in HCV/HIV Coinfected Patients Treated with HCV Protease BI201335, and Drug Drug Interaction Studies with HIV ARTs - (03/04/13)
BI 207127 is a potent HCV RNA polymerase inhibitor during 5 days monotherapy in patients with chronic hepatitis C
http://www.natap.org/2009/AASLD/AASLD_10.htm
4 week therapy with the non-nucleosidic polymerase inhibitor BI 207127 in combination with peginterferon alfa2A and ribavirin in treatment na夫e and treatment experienced chronic HCV GT1 patients
http://www.natap.org/2010/EASL/EASL_34.htm
Safety and antiviral activity of BI 201335, a new HCV NS3 protease inhibitor, in treatment-na夫e patients with chronic hepatitis C genotype 1 infection given as monotherapy and in combination with peginterferon alfa-2a (P) and ribavirin (R)
http://www.natap.org/2008/AASLD/AASLD_13.htm
Presidio Pharmaceuticals Announces Collaboration with Boehringer Ingelheim
The Parties to Initiate a Phase IIa Trial of an All-Oral Combination of Presidio's HCV NS5A inhibitor (PPI-668) with Faldaprevir (BI201335) and BI207127 for the Treatment of Patients with Hepatitis C
SAN FRANCISCO--(BUSINESS WIRE)--Presidio Pharmaceuticals, Inc. announced today a non-exclusive collaboration with Boehringer Ingelheim for a Phase IIa clinical trial of an interferon-free, all-oral, direct-acting antiviral (DAA) combination treatment for patients with chronic hepatitis C virus (HCV) infection. The collaborative trial will evaluate Presidio's pan-genotypic HCV NS5A inhibitor (PPI-668) in combination with Boehringer Ingelheim's HCV protease inhibitor faldaprevir (BI201335) and its non-nucleoside HCV polymerase inhibitor (BI207127), with or without ribavirin.
Both companies have agreed to initiate the Phase II, 12-week treatment study in the second quarter of 2013. The trial will measure on-treatment antiviral responses and sustained virologic response rates (SVR) to the triple DAA combination regimen, with or without ribavirin. Presidio Pharmaceuticals will have primary operational responsibility for the trial, in close collaboration with Boehringer Ingelheim.
"With the potent, complementary antiviral activities of PPI-668, faldaprevir, and BI207127, the present study focuses on patients with HCV genotype-1a infection, which has been harder to treat than HCV genotype-1b in many studies. The study will assess the potential of this three-drug oral regimen to achieve high rates of sustained viral clearance in hepatitis C patients, with good tolerance," said Dr. Nathaniel Brown, Presidio's Chief Medical Officer.
Sustained virologic response results at 4- and 12-weeks post-treatment are expected to be available in the fourth quarter of 2013. Both companies continue to retain all rights to their respective compounds during this collaboration.
About PPI-668
PPI-668 is a potent, pan-genotypic, once daily, NS5A inhibitor. In earlier clinical studies in healthy volunteers and HCV-infected patients, PPI-668 has been well-tolerated to date with no serious or severe adverse events and no apparent pattern of treatment-related clinical side effects or laboratory abnormalities. In a clinical study of PPI-668 monotherapy in GT1 HCV-infected patients, viral load reductions of 3.5 to 3.7 log10 HCV were achieved in 1-2 days.
About faldaprevir (BI201335)
Faldaprevir is an oral once-daily protease inhibitor, specifically designed to target and inhibit viral replication in the liver. Interferon-based therapy with faldaprevir is studied in a broad spectrum of genotype-1 patients. The STARTVerso trial program, which includes treatment-naïve, treatment-experienced and HIV co-infected patients, is nearly complete.
About BI207127
BI207127 is an investigational, potent twice-daily non-nucleoside inhibitor of the HCV polymerase (NS5B) that inhibits HCV genotype-1 replication. BI207127 in combination with faldaprevir and ribavirin is currently in Phase III clinical trials (HCVerso 1 and 2).
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