CENICRIVIROC



NAME OF DRUG : CENICRIVIROC

LABORATORY : ALLERGAN

STATUS AND ADVANCEMENT

Type of drug : CCR2CCR5 Antagonist

Clinical trials advancement : Recruiting Phase 3

The drug got the Fast Track Status granted by the FDA and is eligible for Subpart H on intermediate results of Phase 3

Estimated time to market : 37 months.

LABORATORY ABSTRACT ON THE DRUG

CVC is a dual inhibitor of the CCR2 and CCR5 pathways which play a key role in the cycle of inflammation and fibrosis. CVC has been shown in clinical trials to bind to both CCR2 and CCR5 targets.

HISTORY AND ANALYSIS

The drug is devellopped by TOBIRA therapeutics, TOBIRA  was acquired by ALLERGAN in 2016 !

 

TRIALS IN COURSE AND PLANNED

The 13th of January 2017  a Phase 3 (STELLARIS) was initiated by TOBIRA - ALLERGAN 

STELLARIS: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH

Primary Outcome Measures:
  • Superiority of CVC compared to placebo on liver histology at Month 12 relative to the Screening biopsy [ Time Frame: Measurements at Baseline and 12 months ]
    Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis
  • Superiority of CVC compared to placebo on the composite endpoint of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality [ Time Frame: Time to accrue a pre-specified number of adjudicated events, End of Study, estimated to be 5 years ]
Secondary Outcome Measures:
  • Effect of CVC compared to placebo on liver histology at Month 60 relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage AND no worsening of steatohepatitis [ Time Frame: Time to accrue a pre-specified number of adjudicated events, End of Study, estimated to be 5 years ]

 

The trial plan to include 2000 patients in two arms ( 150 mg of cenicriviroc per os vs placebo )

The recruitment is supposed to start in April 2017 and the first results are expected in July 2019.

The drug seems to be eligible to subpart H .

 

 

 

NASHBIOTECHS OPINION AND LITTLE STORY

The planning seems very optimistic (26 months form start to first results) , enven if the primary outcome is based on 12 months of treatment,  the recuitment can take more than one year , and it is not clear on how many patients they will need to obtain the subpart H ( maybe 1000).

 

 

RECENT NEWS ON CENICRIVIROC

2017-09-22 : New Data from CENTAUR Phase 2b Clinical Study Supports Continued Development of Cenicriviroc (CVC) in Ongoing Phase 3 AURORA Trial

2017-04-19 : Novartis joins forces with Allergan, pushing a NASH combo into late-stage development

2017-01-24 : TOBIRA-ALLERGAN- launch STELLARIS: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH

2016-09-20 : Allergan buy TOBIRA for 1.7 billion $

2016-07-14 : Tobira Therapeutics Announces Clinically and Statistically Significant Improvement in Liver Fibrosis From Phase 2b CENTAUR NASH Trial at One Year

2016-04-12 : Tobira Therapeutics and Dong-A ST Enter Into License Agreements for Evogliptin and Cenicriviroc

SOME PUBLICATIONS RELATED WITH CENICRIVIROC

August 2017 : A Randomized, Placebo-Controlled Trial of Cenicriviroc for Treatment of Nonalcoholic Steatohepatitis with Fibrosis

August 2017 : A Randomized, Placebo-Controlled Trial of Cenicriviroc for Treatment of Nonalcoholic Steatohepatitis with Fibrosis.

May 2016 : Pharmacokinetics, Safety, and CCR2/CCR5 AntagonistActivity of Cenicriviroc in Participants With Mildor Moderate Hepatic Impairment

March 2016 : Efficacy and safety study of cenicriviroc for the treatment of non-alcoholic steatohepatitis in adult subjects with liver fibrosis: CENTAUR Phase 2b study design

SOME NASHBIOTECHS POINTS OF VIEW RELATED WITH CENICRIVIROC

October 2016 : NASH COMBOs ARE THE WAY

September 2016 : TARGETING FIBROSIS ALONE IS A NONSENSE IN NASH

September 2016 : ALLERGAN / TOBIRA DEAL REVEAL A HUGE GAP BETWEEN FINANCIAL ANALYSTS AND BIG PHARMAS FORECAST ON NASH MARKET

August 2016 : STATUS REPORT ON NASH (August 2016)

May 2016 : UPDATE ON THE RACE TO NASH MARKET (May 2016)

November 2015 : GILEADs POSSIBLES STRATEGIES IN NASH

October 2015 : THE NEW DEFINITION OF NASH STRIKE THE NASH PLAYERS

September 2015 : NASH ! TREATMENT’S STRATEGIES AND COMPETITION


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