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Allergan and Novartis combine NASH candidates

3D representation of the liver; ©

Irish Allergan and Swiss Novartis have agreed to start a proof-of-concept study of a combination of their NASH candidates cenicriviroc (Allergan) and FXR agonist LJN452 (Novartis).

As analysts expect an addressable market of US$35bn for treatments of NASH, progressive fibrotic chronic liver inflammation caused by the buildup of fat, which affects at least 2% to 5% of Americans, several companies race for approval of the very first NASH monotherapy. While Genfit’s PPAR agonist elafibranor and  Intercept’s FXR agonist obeticholic acid (OCA) currently are both being tested in Phase III studies, Gilead’s FXR agonist Px104 and Shire’s ASBT inhibitor volixibat follow up with fast-track Phase II trials. Now, Novartis and Allergan have decided to combine Novartis’ FXR agonist LJN452 with Allergan’s dual chemokine receptor (CCR2 and CCR5)-targeting candidate drug cenicriviroc in Phase IIb tests of NASH patients. Financial details of the deal were not disclosed.

In the proof-of-concept study, the partners will assess the safety, efficacy and tolerability of this new approach for NASH. While cenicriviroc, which gained FDA fast track status last year, is currently being evaluated in Phase III trials, Novartis fast-track FXR candidate LJN452 has just been entering Phase II testing.

“Our clinical collaboration with Novartis brings together our collective scientific and development expertise in NASH to focus on multi-therapy treatment, which is expected to be the most likely approach based on the multi-factorial aspects of this disease,” said David Nicholson, Chief R&D Officer, Allergan.

There are currently no approved treatments for NASH.