Allergan posts disappointing data in NASH

It was only last year that Allergan decided to cough up $1.7 billion to acquire Tobira Therapeutics, with the main driver being its lead candidate for NASH, cenicriviroc (CVC). It was a deal that raised a few eyebrows at the time, with the company having just released mixed data on the drug trials but it professed the drug’s strength in reducing fibrosis.

Allergan should then not be surprised to have found itself in a similar position after its latest Phase IIb trial. The treatment spectacularly missed its primary endpoint of a one-stage drop in patients’ disease score alongside the stabilisation of symptoms, with the treatment showing no benefit over placebo.

It left Allergan, similarly to Tobira before it, pointing towards a reduction in fibrosis in a certain subset of patients to recover the results of the trial. It highlighted data showing patients whose condition had worsened over the course of one-year placebo treatment showed some benefit, with 20% of patients receiving CVC, against 13% in placebo, achieving the combined endpoint of reduction in fibrosis by  at least one stage with no worsening of NASH.

"These data confirm the safety profile and anti-fibrotic effect of CVC after one year of treatment. Allergan is committed to advancing our portfolio of NASH treatment programs. We have gained important insights from this analysis which will further support our progress with CVC. The CENTAUR trial is a first of its kind with three biopsies in patients with NASH disease and liver fibrosis. It will help us greatly understand the natural history of NASH and help bring much needed treatment options to patients," said David Nicholson, Chief Research & Development Officer, Allergan.

There is also potential for the treatment as part of a combination treatment, with a deal already having been struck with Novartis for its use alongside LJN452 as a treatment for NASH. This could be where the drug stands to benefit patients most, after such shaky Phase 2 data.

However, Allergan is already moved ahead with a Phase 3 trial of the drug, as it has already begun recruitment into the possibility of using the drug for liver fibrosis in adults with NASH. There will be serious questions raised regarding Allergan’s judgement if this trial also fails to hit its endpoints.