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FDA
Grants Fast Track Review to Schering-Plough's New Oral HCV Protease Inhibitor
SCH 503034 In
a move that shows optimism and gives renewed hope to thousands of chronic hepatitis
C patients currently without viable treatment options, the US Food and Drug Administration
(FDA) has granted Fast Track development status to Schering-Plough’s (SP) experimental
oral HCV protease inhibitor SCH 503034.
The
drug is currently in Phase II clinical development, and sometime in 2007 is expected
to move into Phase III testing, the final stage of clinical testing prior to an
FDA decision on prescription (marketing) status. The
FDA granted Fast Track designation to SCH 503034 for the following reasons, according
to a SP announcement: 
The proposed first indication for SCH 503034 is for treatment of HCV in patients
with HCV
genotype 1 virus who have not responded to combination therapy with
pegylated interferon and ribavirin,
the current standard of care, thus representing an unmet medical need.
SCH 503034 is an orally active inhibitor of the hepatitis C virus serine protease
that inhibits HCV replication. This mechanism is distinct from those of current
therapies; thus SCH 503034 represents a novel class of HCV inhibitor. FDA
grants Fast Track designation to drugs that show promise for treatment of serious
or life-threatening conditions and that demonstrate the potential to address unmet
medical needs. An important feature of Fast Track designation is that it emphasizes
the critical nature of close, early communication between the FDA and the sponsor
company to improve the efficiency of product development. In
its press announcement, SP made the following additional statements about the
development program for SCH 503034: Status of SCH 503034 Clinical Development SCH
503034 has demonstrated potent antiviral activity and was well-tolerated, both
as monotherapy [1] and in combination with PegIntron (peginterferon alfa-2b) [2]
in Phase I clinical studies in patients chronically
infected with HCV genotype 1 who were nonresponders
to previous therapy, including peginterferon and ribavirin combination
therapy. Results
of Phase I clinical studies with SCH 503034, including in healthy (HCV-negative)
subjects, [3] were presented at the 56th
Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
in November 2005. HCV genotype 1 is the most common form of the virus worldwide
and is considered the most difficult to treat successfully. Phase II Study Ongoing Based
on the results of the Phase I clinical program and extensive preclinical safety
and pharmacology studies, Schering-Plough is conducting a large, randomized Phase
II dose-finding study involving 300 patients worldwide. This study evaluates
the safety and efficacy of SCH 503034 in combination with PegIntron,
with and without added ribavirin, for 24 or 48 weeks
in patients with chronic HCV genotype 1 who were nonresponders
to previous peginterferon and ribavirin
combination therapy. The
primary objective of this study is to determine the safe and effective dose range
of SCH 503034 in combination with PegIntron in this
patient population. A secondary objective is to explore whether or not ribavirin provides an additional benefit when combined
with SCH 503034 plus PegIntron. Additionally,
an extensive preclinical and Phase I clinical development program is ongoing to
support the potential broad utility of SCH 503034 in treating chronic hepatitis
C.
More SCH 503034 Articles on HIV
and Hepatitis.com SCH
503034 Suppresses Polyprotein Maturation and Enhances
the Antiviral Activity of Interferon Alfa-2b... SCH
503034, an Experimental HCV Protease Inhibitor from Schering
... Hepatitis C Experimental
Treatments / Monotherapy and Combination Pharmacokinetics
and Safety of the Experimental, Oral HCV Protease ... Schering
Expected to Present Results of Phase 1 Clinical Study of ... New Experimental
HCV Drugs in Development Hepatitis C Top Articles Update
on Experimental Therapies for Chronic Hepatitis C Infection Pharmacokinetics Peginterferon Alfa-2b (PegIntron)
as Maintenance Monotherapy for ... HIVandHepatitis.com
Coverage of Highlights from the 56th AASLD More about
PegIntron and PegIntron+Rebetol
(Ribavirin) on HIV and Hepatitis.com 01/31/06 Source Schering-Plough. Schering-Plough Reports FDA Grants Fast Track Designation
to Oral HCV Protease Inhibitor SCH 503034. Press Release.
January 30, 2006. References 1.
S Zeuzem et al. Antiviral Activity of SCH 503034, a HCV Protease
Inhibitor, Administered as Monotherapy in Hepatitis
C Genotype-1 (HCV-1) Patients Refractory to Pegylated
Interferon (Peg-IFN-a), Abstract 67484, AASLD 2005. 2.
S Zeuzem et al. Combination therapy with the HCV Protease Inhibitor,
SCH 503034, Plus PEG-INTRON in Hepatitis C Genotype-1 PEG-INTRON Nonresponders: Phase Ib Results,
Abstract 67627, AASLD 2005. 3.
J Zhang et al. Single Dose Pharmacokinetics of a Novel Hepatitis C Protease Inhibitor,
SCH 503034, in an Oral Capsule Formulation, Abstract 66787, AASLD 2005. | 
