Date: 2017-01-13
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Tobira Therapeutics (USA - CA), now Allergan (Ireland)
Product: cenicriviroc (CVC)
Action mechanism: immunomodulating agent/CCR5 co-receptor antagonist/CCR2 antagonist. Cenicriviroc (CVC) is a once-daily, oral, Phase III ready potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in inflammatory and fibrogenic pathways. In the Phase IIb CENTAUR study, CVC demonstrated a clinically meaningful improvement in fibrosis of at least one stage without worsening of NASH after one year of treatment. CVC has been granted Fast Track designation by the FDA in patients with NASH and liver fibrosis. Cenicriviroc has been developed by Tobira Therapeutics. Allergan has acquired the company last year to strengthen its global gastroenterology R&D pipeline.
Disease: liver fibrosis in adult subjects with NASH
Therapeutic area: Hepatic diseases - Liver diseases
Country: Puerto Rico, USA
Trial details: The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH. (NCT03028740)
Latest news: • On January 13, 2017, a Phase 3 trial sponsored by Tobi Therapeutics was published on the NIH website ClinicalTrials.gov for durvalumab (MEDI4736) and is currently recruiting participants.
