Conatus Announces Results from ENCORE-PH Phase 2b Clinical Trial in NASH Cirrhosis

Conatus Pharmaceuticals (Nasdaq:CNAT) today announced top-line results from the company’s Phase 2b ENCORE-PH clinical trial showing clinically meaningful treatment effects in compensated NASH cirrhosis patients at high risk of decompensation.

As quoted in the press release:

The total patient population was composed of two prespecified subgroups – patients with compensated NASH cirrhosis (201 of 263 patients, or 76%) and patients with early decompensated NASH cirrhosis (62 of 263 patients, or 24%). Steven J. Mento, Ph.D., President, Chief Executive Officer and co-founder of Conatus, said, “Based on previous discussions with regulators, we expect that separate registration trials would be needed in compensated and decompensated NASH cirrhosis. This trial purposely enrolled mostly compensated patients, and we are encouraged by the treatment effect shown in this population in these top-line results.”

In patients with compensated NASH cirrhosis, post hoc analyses demonstrated consistent improvements in mean HVPG at week 24 over baseline. In these same patients, clinically meaningful differences compared with placebo in mean HVPG at Week 24 were observed in a consistent pattern over multiple baseline HVPG cohorts from ≥13 mmHg through ≥17 mmHg. The magnitude of the improvement in mean HVPG generally increased as the baseline HVPG levels increased. Both the 25mg and 50mg active dose groups achieved a >10% improvement in mean HVPG compared with placebo in all HVPG cohorts from ≥13 mmHg through ≥17 mmHg, while placebo-treated patients showed increases in mean HVPG. The greatest improvement was observed in patients with a baseline HVPG of 16 mmHg or higher.

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