Tuesday, March 16, 2010 12:18:17 PM
ONCE-DAILY NS5A INHIBITOR (BMS-790052) PLUS PEGINTERFERON-ALPHA-2A AND RIBAVIRIN PRODUCES HIGH RATES OF EXTENDED RAPID VIROLOGIC RESPONSE IN TREATMENT-NAIVE HCV-GENOTYPE 1 SUBJECTS: PHASE 2A TRIAL
http://www.kenes.com/easl2010/Orals/297.htm
S. Pol1, G. Everson2, R. Ghalib3, V. Rustgi4, C. Martorell5, H.A. Tatum6, J. Lim7, C. Hezode8, U. Diva9, P.D. Yin9, R. Hindes9
1Hôpital Cochin, Paris, France, 2University of Colorado Denver & Hospital, Denver, CO, 3The Liver Institute at Methodist Dallas Medical Center, Dallas, TX, 4Metropolitan Research, Fairfax, VA, 5The Research Institute, Springfield, MA, 6Options Health Research, Tulsa, OK, 7Yale University School of Medicine, New Haven, CT, USA, 8CHU Henri Mondor, Creteil, France, 9Bristol-Myers Squibb Company, Wallingford, CT, USA. *stanislas.pol@cch.aphp.fr
Background: BMS-790052 is a first-in-class, highly potent, once-daily HCV NS5A inhibitor. In Phase I studies in HCV-infected subjects, BMS-790052 was well-tolerated and exhibited potent antiviral activity.
Methods: In this double-blind study, 48 subjects were randomized 1:1:1:1 to receive placebo, 3 mg, 10 mg or 60 mg of BMS-790052, once-daily in combination with peginterferon-alpha-2a and ribavirin (P/R) for 48 weeks in treatment-naive HCV genotype 1-infected subjects. The primary endpoint was the proportion of subjects with extended rapid virologic response (eRVR) defined as HCV RNA < 10 IU/mL at both Weeks 4 and 12.
Results: Subject baseline and demographic characteristics were well-balanced across treatment arms (n = 12/arm), with mean baseline HCV RNA 6.5 log10 IU/mL. The proportion of subjects achieving eRVR was 42%, 83% and 75% in the 3 mg, 10 mg and 60 mg BMS-790052 + P/R arms, respectively, compared to 8% for P/R. Safety was comparable across treatment arms (see table). Adverse events were consistent with those commonly observed with P/R. Confirmed viral breakthrough was not observed in the 10 mg and 60 mg BMS-790052 arms through Week 12.
Conclusions: BMS-790052 is a potent once-daily NS5A inhibitor that yielded higher eRVR, RVR, and cEVR rates when combined with P/R than P/R alone. The addition of BMS-790052 to P/R was well-tolerated with an AE profile comparable to P/R. These results support further development of BMS-790052 in combination with P/R or other HCV antivirals.
http://www.kenes.com/easl2010/Orals/297.htm
S. Pol1, G. Everson2, R. Ghalib3, V. Rustgi4, C. Martorell5, H.A. Tatum6, J. Lim7, C. Hezode8, U. Diva9, P.D. Yin9, R. Hindes9
1Hôpital Cochin, Paris, France, 2University of Colorado Denver & Hospital, Denver, CO, 3The Liver Institute at Methodist Dallas Medical Center, Dallas, TX, 4Metropolitan Research, Fairfax, VA, 5The Research Institute, Springfield, MA, 6Options Health Research, Tulsa, OK, 7Yale University School of Medicine, New Haven, CT, USA, 8CHU Henri Mondor, Creteil, France, 9Bristol-Myers Squibb Company, Wallingford, CT, USA. *stanislas.pol@cch.aphp.fr
Background: BMS-790052 is a first-in-class, highly potent, once-daily HCV NS5A inhibitor. In Phase I studies in HCV-infected subjects, BMS-790052 was well-tolerated and exhibited potent antiviral activity.
Methods: In this double-blind study, 48 subjects were randomized 1:1:1:1 to receive placebo, 3 mg, 10 mg or 60 mg of BMS-790052, once-daily in combination with peginterferon-alpha-2a and ribavirin (P/R) for 48 weeks in treatment-naive HCV genotype 1-infected subjects. The primary endpoint was the proportion of subjects with extended rapid virologic response (eRVR) defined as HCV RNA < 10 IU/mL at both Weeks 4 and 12.
Results: Subject baseline and demographic characteristics were well-balanced across treatment arms (n = 12/arm), with mean baseline HCV RNA 6.5 log10 IU/mL. The proportion of subjects achieving eRVR was 42%, 83% and 75% in the 3 mg, 10 mg and 60 mg BMS-790052 + P/R arms, respectively, compared to 8% for P/R. Safety was comparable across treatment arms (see table). Adverse events were consistent with those commonly observed with P/R. Confirmed viral breakthrough was not observed in the 10 mg and 60 mg BMS-790052 arms through Week 12.
Conclusions: BMS-790052 is a potent once-daily NS5A inhibitor that yielded higher eRVR, RVR, and cEVR rates when combined with P/R than P/R alone. The addition of BMS-790052 to P/R was well-tolerated with an AE profile comparable to P/R. These results support further development of BMS-790052 in combination with P/R or other HCV antivirals.
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