Five months after Novartis stepped up to collaborate with Allergan on a combo NASH program, Allergan $AGN has followed up with what it describes as an encouraging followup snapshot to the mid-stage data for their drug cenicriviroc.
But that could take some explaining.
Their drug — which flat failed the primary and one secondary in the Phase IIb — unsurprisingly missed the composite endpoint looking at a one-stage drop in patients’ disease score with symptoms stabilizing.
After two years of treatment, there was no significant separation between the drug and the placebo.
In what looks more like a base hit at best, Allergan says the latest update from the Phase IIb trial also shows that 20% of the placebo patients who crossed over to the drug arm in year 2 hit the combined primary endpoint with a minimum one-stage drop in their disease score with no worsening of symptoms. The placebo arm rate was 13%.
If you look just at the one-stage drop endpoint, the breakout was a more encouraging 35% compared to 20%. And researchers touted a better score among patients with high levels of fibrosis with plans to pursue some additional analysis to see how best to position this drug.
These kind of mixed data on this drug is not what Allergan’s backers want to see at this point. But the exec crew says they are eagerly pursuing the Phase III, recruiting 2,000 patients with a one-year endpoint they believe they can hit. And R&D chief David Nicholson says any weakness in the new Phase IIb update was due to missing data and an unanticipated placebo response — none of which is dulling his enthusiasm for Phase III.
In a statement to Endpoints News, he noted:
“The data we have accumulated convinces both Allergan, as well as our external experts, that CVC has antifibrotic activity in patients suffering from NASH. Our phase 2 CENTAUR study has twice and independently shown a reduction in fibrosis following 1 year of treatment. This antifibrotic activity is most prominent in severely ill patients, and unlike placebo treated patients, it was durable in the majority of patients receiving CVC. The studies performed to date indicate that CVC can be safely administered to NASH patients. As it relates to the year two data, the results were confounded by missing data, and higher than expected placebo rates, namely in patients with early stage disease; this was not unanticipated. Larger Phase 3 studies are now needed, as always, to confirm the efficacy and safety profile suggested by our phase 2 data.”
Allergan agreed to pay up to $1.7 billion to buy this drug in their acquisition of Tobira last fall, a 6x premium that surprised quite a few analysts after the biotech saw its Phase IIb study flop and its share price was crushed. The drug hit one of the secondaries, though, which encouraged Allergan to step in.
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