| |
9 & Soon 11 New HCV Drugs in Phase 3
|
| |
| |
Shortly before AASLD Abbott announced the start of their phase 3 studies which will examine the coformulation of ABT450/r (protease) + ABT267 (NS5A) + their non-nuc + rbv. In addition Gilead is starting a phase 3 study looking at their coformulation of GS7977+ GS5885 (NS5A) + rbv.
Abbott Phase 3 Study - (10/17/12)
BMS052 HCV-NS5A Monotherapy in Phase 3 Now
GS-7977 HCV Nucleotide in Phase 3 Now
Peginterferon Lambda: new interferon in phase 3 now
BI1335 HCV Protease in Phase 3 Now
TMC-435 HCV Protease in Phase 3 -
BMS032 HCV Protease in Phase 3 Now -
"Rapid progress has been made with the HCV Research Program and we now have a comprehensive Phase III development program" John Martin CEO Gilead........"In May and June of this year, discussions were held with the U.S. FDA and 3 European regulatory agencies, and agreement has been achieved on a comprehensive Phase III development plan for GS-7977 and on a Phase III plan for GS-7977 in combination with the NS5A inhibitor, GS-5885.......we anticipate being able to file for regulatory approvals for GS-7977 by the middle of next year.......If successful, the initial indication will for 12 to 16 weeks of treatment with GS-7977 and Ribavirin in genotype 2/3 infected patients, and for 12 weeks of treatment with GS-7977, peg-interferon and Ribavirin in genotype 1, 4, 5 and 6 infected patients......we plan to advance the fixed dose combination of GS-7977 and 5885, currently in Phase I clinical testing, into Phase III in the fourth quarter of this year.....GS-7977 and GS-5885 were successfully co-formulated into a single pill, fixed dose combination......The fixed dose combination regulatory filings could, in that case, follow the initial GS-7977 filings a year later by mid-2014"....."The Food and Drug Administration is allowing a nonstandard-of-care controlled phase III study for 7977/5885" from Barron's online [we know the FDA is allowing this for all IFN-free therapy development studies from all companies]
Gilead Begins Single Pill Hepatitis C Study for 2014 Approval - (07/27/12)
both Abbott & Gilead have coformulated their 2 drugs into one pill taken once daily: Abbott's protease ABT450/r + their NS5A ABT267; Gilead's GS7977 + their NS5A GS5885.
AASLD:High Rate of Sustained Virologic Response With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) Plus Sofosbuvir (Nucleotide NS5B Inhibitor), With or Without Ribavirin, in Treatment-Naive Patients Chronically Infected With HCV GT 1, 2, or 3- (11/13/12) with 12 or 24 weeks 2-drug therapy 100% cure rates
AASLD:An Interferon-Free, Ribavirin-Free 12-Week Regimen of Daclatasvir (DCV), Asunaprevir (ASV), and BMS-791325 Yielded SVR4 of 94% in Treatment-Naïve Patients with Genotype (GT) 1 Chronic Hepatitis C Virus (HCV) Infection- (11/13/12)
AASLD:Once Daily Sofosbuvir (GS-7977) Regimens in HCV Genotype 1-3: The ELECTRON Trial- (11/14/12) 100% Cure rate: GS7977+GS5885
AASLD:A 12-week Interferon-free Treatment Regimen With ABT-450/r, ABT 267, ABT-333, and Ribavirin Achieves SVR12 Rates (Observed Data) of 99% in Treatment-naïve Patients and 93% in Prior Null Responders With HCV Genotype 1 Infection- (11/13/12)
IFN/RBV+GS7977 97-100% Cure Rates:
AASLD:Once Daily Sofosbuvir (GS-7977) plus PEG/RBV In Treatment-Naïve Patients With HCV Genotype 1, 4, and 6 Infection: The ATOMIC Study- (11/14/12)
--------------------------------
--------------------------------
New Protease by Roche who recently started the AnnaPurna Study which looks at 4-drug oral regimen IFN-free:
AASLD:Up to 100% SVR4 rates with ritonavir-boosted danoprevir (DNVr), mericitabine and ribavirin with or without peginterferon alfa-2a (40KD) in HCV genotype 1-infected partial and null responders: results from the MATTERHORN study- (11/13/12)
AASLD:Safety and efficacy of ritonavir-boosted danoprevir (DNVr), peginterferon alfa-2a (40KD), and ribavirin with or without mericitabine in HCV genotype 1-infected treatment-experienced patients with advanced hepatic fibrosis: the MATTERHORN study- (11/13/12)
ALSO NEW PROTEASE INHIBITORS:
New protease in phase 3 - AASLD:Efficacy and tolerability of simeprevir (TMC435) 150 mg once daily with peginterferon and ribavirin for treatment of HCV genotype 1 infection in patients with Metavir score F3 and F4 (PILLAR and ASPIRE trials)- (11/13/12)
AASLD:Safety and tolerability of simeprevir (TMC435) in combination with peginterferon a-2a and ribavirin for treatment of HCV genotype 1 infection in treatment-naïve and -experienced patients (Phase IIb PILLAR and ASPIRE Trials)- (11/13/12)
IFN--Free REgimen with new protease in phase 3:
AASLD:EFFICACY AND SAFETY OF THE INTERFERON-FREE COMBINATION OF FALDAPREVIR (BI 201335) + BI 207127 ± RIBAVIRIN IN TREATMENT-NAIVE PATIENTS WITH HCV GT-1 AND COMPENSATED LIVER CIRRHOSIS: RESULTS FROM THE SOUND-C2 STUDY - (11/14/12)
AASLD:INTERFERON (IFN)-FREE COMBINATION TREATMENT WITH THE HCV NS3/4A PROTEASE INHIBITOR FALDAPREVIR (BI 201335) AND THE NON-NUCLEOSIDE NS5B INHIBITOR BI 207127 ± RIBAVIRIN: FINAL RESULTS OF SOUND-C2 AND PREDICTORS OF RESPONSE- (11/14/12)
NEW NUCLEOTIDE, the same class as drug as GS-7977, this is the only other drug in the same class. these are results from 7 day monotherapy study of this drug ALS2200 showing it is potent, the company Vertex just signed a deal with 2 other companies to begin IFN-free combo studies: with GSK & their NS5A & with Janssen & their new protease TMC435:
AASLD:ALS-2200, A Novel Once-daily Nucleotide HCV Polymerase Inhibitor, Demonstrates Potent Antiviral Activity Over 7 Days in Treatmentnaïve Genotype 1 (GT1) Patients- (11/13/12)
MERCK is developing these 2 potent drugs, their NS5A & their 2nd generation protease - AASLD:Safety and Sustained Viral Response of MK-5172 for 12 Weeks in Combination With Pegylated Interferon Alfa-2b and Ribavirin for 24 Weeks in HCV Genotype 1 Treatment-Naive Noncirrhotic Patients - (11/13/12)
AASLD:A Combination Containing MK-5172 (HCV NS3 protease inhibitor) and MK-8742 (HCV NS5A inhibitor) Demonstrates High Barrier to Resistance in HCV Replicon- (11/13/12)
|
|
| |
| |
|
|
|
