Type of information: Clinical research agreement
Compound: LJN452 (FXR agonist) and cenicriviroc (CVC)
Company: Allergan (Ireland) Novartis (Switzerland)
Therapeutic area: Hepatic diseases - Liver diseases
Type agreement: clinical research
Action mechanism: farnesoid X receptor agonist/FXR agonist/
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: NASH (non-alcoholic steatohepatitis)
- • On April 18, 2017, Novartis announced that it has entered into a clinical trial agreement with Allergan to conduct a Phase IIb study, involving the combination of a Novartis FXR agonist and Allergan's cenicriviroc (CVC) for the treatment of non-alcoholic steatohepatitis (NASH).
Novartis is developing Farnesoid X receptor (FXR) agonists for the treatment of chronic liver diseases, including NASH. The most advanced investigational compound, LJN452, is a potent, non-bile acid FXR agonist, which recently received Fast Track designation from the FDA and is in a Phase II clinical trial. As part of this agreement, Novartis and Allergan will conduct a Phase IIb clinical trial to assess the safety, efficacy and tolerability of a combination therapy for NASH.
In December 2016, Novartis announced an exclusive option for a collaboration and license agreement with Conatus Pharmaceuticals to jointly develop emricasan for NASH. Emricasan is an investigational, first-in-class, oral, pan-caspase inhibitor and our agreement with Conatus has the potential to expand treatment options for people in various stages of NASH, including those with the advanced form of the disease, NASH cirrhosis. Both collaborations with Conatus and Allergan continue to support the growing Novartis portfolio to develop new therapies in chronic liver diseases, including NASH.
Financial terms: The financial details of this transaction are not disclosed.