Abbott
and Enanta To Start Phase 2 Trial of HCV Protease Inhibitor ABT-450
and Polymerase Inhibitors ABT-333 and ABT-072
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| SUMMARY:
Abbott and Enanta Pharmaceuticals announced this week
that they will initiate a Phase 2 clinical trial to
test for 3 directly targeted oral drugs for hepatitis
C virus (HCV) infection, the protease inhibitor
ABT-450 (from the Abbott/Enanta collaboration) and 2
Abbott HCV polymerase inhibitors, ABT-333 and ABT-072.
Each agent will be studied in combination with pegylated
interferon plus ribavirin standard therapy now,
but offer the potential for all-oral regimens in the
future. |
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With
the most advanced directly targeted oral hepatitis C drug now
in Phase 3 trials, investigators have begun to look at all-oral
combination regimens, which are expected to slow emergence of
resistance and could potentially allow people with hepatitis C
to avoid the side effects of pegylated interferon and ribavirin.
Roche/Genentech
was the first to test such a combination, the HCV protease inhibitor
RG7227 (also known as ITMN-191) plus the polymerase inhibitor
RG7128; the first results from the INFORM-1
trial were presented this past fall. Vertex also announced
this week that it will soon start studies of combination regimens
containing its lead HCV
protease inhibitor telaprevir plus the investigational HCV
polymerase inhibitor VX-222.
Below
is an excerpt from the recent Abbott/Enanta press release announcing
their forthcoming studies.
Abbott
and Enanta Announce Advancement of
Hepatitis C Collaboration
Initiation of Phase 2 Clinical Trial
Investigating Three Individual HCV Antivirals
Abbott
Park, Ill. and Watertown, Mass. -- March 2, 2010. - Abbott (NYSE:
ABT) and Enanta Pharmaceuticals announced today the advancement
of their Hepatitis C (HCV) collaboration into Phase 2 clinical
trials. The trial will evaluate three HCV antiviral agents, including
the investigational protease inhibitor ABT-450, part of the Abbott-Enanta
collaboration, and polymerase inhibitors ABT-333 and ABT-072 currently
being developed exclusively by Abbott. Each antiviral agent will
be dosed individually in combination with the current standard
of care (SOC).
ABT-450 was discovered as part of an alliance between Abbott and
Enanta. ABT-333 and ABT-072, both discovered internally at Abbott,
are part of the company's ongoing non-nucleoside polymerase inhibitor
development program.
"Our scientists are working diligently to advance the treatment
of Hepatitis C, which is a serious global epidemic that affects
170 million people worldwide," said John M. Leonard, MD,
senior vice president, Global Pharmaceutical Research and Development,
Abbott. "As a global leader in the development of antiviral
therapies, we are focused on building an industry-leading pipeline
for the treatment of HCV and are well-positioned to explore multiple
potent and new classes of HCV therapies that hold promise for
patients."
While significant progress has been made in HCV treatment, there
are limitations in efficacy and safety for the current standard
of care. An extended duration of treatment (24 or 48 week course
of a combination of pegylated alpha interferon and ribavirin)
still results in a less-than 50% cure rate in those with HCV genotype
1. Additionally, the side-effects from interferon therapy can
be highly problematic, often including depression and flu-like
symptoms.
"Initiating Phase 2 is a key step in advancing our HCV collaboration,"
said Jay R. Luly, PhD, president and CEO of Enanta Pharmaceuticals.
"We look forward to working with Abbott to advance our shared
vision of creating breakthrough treatments for HCV infection."
The objectives of the Phase 2 study are to assess the safety,
tolerability, pharmacokinetics, and antiviral activity of multiple
dose strengths of ABT-450 or ABT-333 or ABT-072, each dosed individually
in treatment-naïve adults infected with HCV genotype 1, the
most common and difficult to treat form of the infection in the
developed world. Initial antiviral activity will be evaluated
via a 3-day monotherapy period. Subsequently, each antiviral agent
will be administered with pegIFN/RBV (SOC) for 12-weeks, followed
by treatment with SOC alone for an additional 36-weeks. Participants
will then be monitored for sustained virologic response (SVR).
About Enanta
Enanta Pharmaceuticals is a research and development company that
uses its novel chemistry approach and drug discovery capabilities
to create best in class small molecule drugs in the infectious
disease field. Enanta is developing novel protease, NS5A, polymerase,
and cyclophilin-based inhibitors targeted against the Hepatitis
C virus (HCV). Additionally, the Company has created a new class
of macrolide antibiotics, called Bicyclolides, which overcomes
bacterial resistance. Antibacterial focus areas include superbugs,
respiratory tract infections, and intravenous and oral treatments
for hospital and community MRSA. Enanta is a privately held company
headquartered in Watertown, MA. Enanta's news releases and other
information are available on the company's web site at www.enanta.com.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company
devoted to the discovery, development, manufacture and marketing
of pharmaceuticals and medical products, including nutritionals,
devices and diagnostics. The company employs approximately 83,000
people and markets its products in more than 130 countries.
For more information, see www.abbott.com.
3/5/10
Source
Abbott and Enanta Pharmaceuticals. Abbott and Enanta Announce
Advancement of Hepatitis C Collaboration. Press release. March
2, 2010.
