NAME OF DRUG : CENICRIVIROC
ALSO KNOWN AS : 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 : 26 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
- 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 ]
- 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
2018-06-11 : A critical review of endpoints for non-cirrhotic NASH therapeutic trials
2018-04-18 : Novartis expands development programs for NASH through clinical collaboration with Allergan
2017-04-19 : Novartis joins forces with Allergan, pushing a NASH combo into late-stage development
2016-09-20 : Allergan buy TOBIRA for 1.7 billion $
2016-04-12 : Tobira Therapeutics and Dong-A ST Enter Into License Agreements for Evogliptin and Cenicriviroc
SOME PUBLICATIONS RELATED WITH CENICRIVIROC
June 2018 : A critical review of endpoints for non-cirrhotic NASH therapeutic trials
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.
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 ! TREATMENTS STRATEGIES AND COMPETITION