Drug name: Cenicriviroc
Mechanism: CCR type 2/5 dual antagonist
Stage: Phase 3
Next readout: Topline AURORA data expected in Q4 2020
Allergan picked up its lead NASH program, cenicriviroc, in its 2016 acquisition of Tobira Therapeutics. The drug had just failed a phase 2b trial in NASH, missing its primary endpoint of reducing a measure of fatty liver disease activity—called the NAS score—by two points. However, it delivered on one of two key secondary endpoints: improving fibrosis by at least one stage without the worsening of NASH. With regulators’ support, Tobira decided this should be the endpoint of cenicriviroc’s phase 3 program. And after inking a deal that could be worth $1.69 billion, Allergan is carrying the trial forward.
Also called CVC, cenicriviroc is a once-daily pill that blocks two chemokine receptors, CCR2 and CCR5, which are involved in inflammatory and fibrogenic pathways. The phase 3 AURORA study aims to enroll about 2,000 patients with NASH. The first part of the study is pitting CVC against placebo in NASH patients with stage 2 or stage 3 fibrosis, according to ClinicalTrials.gov. The second part of the trial will zero in on patients with more severe disease—that is, those with stage 3 fibrosis. Allergan has also teamed up with Novartis to test CVC in tandem with the latter’s FXR agonist tropifexor in a phase 2b study.
Bernstein analysts said the “deal partially validates Allergan’s acquisition of CVC” and also “make[s] us suspect NVS may have been the other bidder.”
Though CVC works through a different mechanism than Intercept’s obeticholic acid and Genfit’s elafibranor, which are expected to beat it to market, CVC will have an uphill battle: “The profile of the drug in phase 2 was decent (not great) and assuming approval, Allergan will need to develop the market (certainly if Genfit and Intercept remain independent). We do not see this as an important commercial asset until at least 2024,” the analysts wrote.
And if CVC doesn’t pan out, Allergan has a couple of preclinical-stage FXR agonists it obtained in its 2016 buyout of another NASH biotech: Akarna Therapeutics.