|[March 13, 2013]
Presidio Pharmaceuticals Announces Collaboration with Boehringer Ingelheim
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
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
areexpected to be available in the fourth quarter of 2013. Both
companies continue to retain all rights to their respective compounds
during this collaboration.
About Hepatitis C
Chronic hepatitis C is a progressive inflammatory liver disease caused
by chronic infection with the hepatitis C virus (HCV). Approximately 170
to 200 million persons have chronic HCV infection worldwide, resulting
in more than 350,000 deaths annually.
The current standard treatment for patients with hepatitis C genotype-1
infection in the United States and several other countries is combined
administration of pegylated interferon-alfa, ribavirin, and an HCV
Due to the efficacy limitations and tolerance issues for
interferon-based therapies and the continuing progression of underlying
liver damage in the current large population of hepatitis C patients,
there is a continuing need for more effective, better-tolerated,
interferon-free combination therapies for HCV infection that can be
orally administered with convenient, relatively short dosing schedules.
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-na�ve, treatment-experienced and HIV co-infected patients, is
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).
Presidio Pharmaceuticals, Inc. is a San Francisco-based clinical stage
specialty pharmaceutical company focused on the discovery and
development of novel oral antiviral therapeutics. For more information,
please visit our website at: www.presidiopharma.com
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